Product Labeling for Laparoscopic Power Morcellators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 11093-11094 [2020-03827]
Download as PDF
Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices
Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03860 Filed 2–25–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1804]
Product Labeling for Laparoscopic
Power Morcellators; Draft Guidance for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announcing the availability of the draft
guidance entitled ‘‘Product Labeling for
Laparoscopic Power Morcellators.’’ This
draft guidance proposes updated
‘‘Contraindications’’ and ‘‘Warnings’’ in
product labeling information to reflect
the state of the science and available
technology regarding use of
laparoscopic power morcellators
(LPMs). This draft guidance is not final
nor is it in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by April 27, 2020 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draft guidance before it begins work on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:
SUMMARY:
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.
VerDate Sep<11>2014
17:22 Feb 25, 2020
Jkt 250001
• 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–1804 for ‘‘Product Labeling for
Laparoscopic Power Morcellators.’’
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.
• 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://
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
11093
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.
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 ‘‘Product Labeling for
Laparoscopic Power Morcellators’’ to
the Office of Policy, 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 selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Veronica Price, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2659, Silver Spring,
MD 20993–0002, 301–796–6538.
SUPPLEMENTARY INFORMATION:
I. Background
Following issuance of the 2014
guidance document entitled
‘‘Immediately in Effect Guidance
Document: Product Labeling for
Laparoscopic Power Morcellators,’’
(https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/immediately-effectguidance-document-product-labelinglaparoscopic-power-morcellators) FDA
continued to consider new scientific
information and the input of
stakeholders. Additional scientific
information is available that stratifies
the risks of an undetected uterine cancer
in women with presumed fibroids based
on age.
FDA also considered scientific
information pertaining to the risk of
spreading benign uterine tissue beyond
the uterus during gynecologic surgeries
when LPMs are used. Parasitic myomas
and disseminated peritoneal
leiomyomatosis, while benign, have
been associated with the need for
additional surgery due to symptoms
E:\FR\FM\26FEN1.SGM
26FEN1
11094
Federal Register / Vol. 85, No. 38 / Wednesday, February 26, 2020 / Notices
such as abdominal pain and distension.
Finally, FDA considered additional
available mitigations for the spread of
uterine tissue. Since 2014, FDA has
provided marketing authorization for
LPM containment systems intended to
isolate and contain tissue that is
considered benign. These products have
been shown, through bench testing and
simulated use testing, to contain such
tissue during morcellation.
For these reasons, FDA is proposing
in this draft guidance to update its
recommendations, as originally
described in the 2014 guidance
document, concerning the content and
format of certain labeling information
for LPMs. Specifically, FDA is
recommending that manufacturers
incorporate into the labeling for these
devices information providing greater
specificity regarding the risks of use as
it relates to age, information regarding
the risk of spreading benign uterine
tissue, and information regarding the
use of LPM containment systems.
FDA considered comments received
on the final guidance document that
appeared in the Federal Register of
November 25, 2014 (79 FR 70193). FDA
revised the guidance as appropriate in
response to the comments.
II. Significance of Guidance
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 ‘‘Product Labeling for Laparoscopic
Power Morcellators.’’ 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.
III. 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
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information. 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. 3501–3521). The
collections of information in the
following FDA regulations have been
approved by OMB as listed in the
following table:
21 CFR part
Topic
807, subpart E ..............................................................................................................
800, 801, and 809 ........................................................................................................
803 ................................................................................................................................
Premarket notification ...............................
Medical Device Labeling Regulations ......
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer
reporting, user facility reporting, distributor reporting.
Dated: February 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03827 Filed 2–25–20; 8:45 am]
BILLING CODE 4164–01–P
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
Comments on this ICR should be
received no later than April 27, 2020.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Shortage
Designation Management System
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
SUMMARY:
VerDate Sep<11>2014
17:22 Feb 25, 2020
Jkt 250001
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
ADDRESSES:
Health Resources and Services
Administration
khammond on DSKJM1Z7X2PROD with NOTICES
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 ‘‘Product Labeling for Laparoscopic
Power Morcellators’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1400052 to identify the
guidance you are requesting.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
FOR FURTHER INFORMATION CONTACT:
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Shortage Designation Management
System OMB No. 0906–0029—Revision.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
OMB control
No.
0910–0120
0910–0485
0910–0437
Abstract: HRSA’s Bureau of Health
Workforce is committed to improving
the health of the Nation’s underserved
communities and vulnerable
populations by developing,
implementing, evaluating, and refining
programs that strengthen the nation’s
health workforce. HHS relies on two
federal shortage designations to identify
and dedicate resources to areas and
populations in greatest need of
providers: Health Professional Shortage
Area (HPSA) designations and
Medically Underserved Area/Medically
Underserved Population (MUA/P)
designations. HPSA designations are
geographic areas, population groups,
and facilities that are experiencing a
shortage of health professionals. The
authorizing statute for the National
Health Service Corps (NHSC) created
HPSAs to fulfill the statutory
requirement that NHSC personnel be
directed to areas of greatest need. To
further differentiate areas of greatest
need, HRSA calculates a score for each
HPSA. There are three categories of
HPSAs based on health discipline:
Primary care, dental health, and mental
health. Scores range from 1 to 25 for
E:\FR\FM\26FEN1.SGM
26FEN1
Agencies
[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Notices]
[Pages 11093-11094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1804]
Product Labeling for Laparoscopic Power Morcellators; Draft
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 draft guidance entitled ``Product Labeling for
Laparoscopic Power Morcellators.'' This draft guidance proposes updated
``Contraindications'' and ``Warnings'' in product labeling information
to reflect the state of the science and available technology regarding
use of laparoscopic power morcellators (LPMs). This draft guidance is
not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by April 27, 2020 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:
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-1804 for ``Product Labeling for Laparoscopic Power
Morcellators.'' 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.
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.
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
``Product Labeling for Laparoscopic Power Morcellators'' to the Office
of Policy, 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: Veronica Price, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2659, Silver Spring, MD 20993-0002, 301-796-6538.
SUPPLEMENTARY INFORMATION:
I. Background
Following issuance of the 2014 guidance document entitled
``Immediately in Effect Guidance Document: Product Labeling for
Laparoscopic Power Morcellators,'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immediately-effect-guidance-document-product-labeling-laparoscopic-power-morcellators) FDA
continued to consider new scientific information and the input of
stakeholders. Additional scientific information is available that
stratifies the risks of an undetected uterine cancer in women with
presumed fibroids based on age.
FDA also considered scientific information pertaining to the risk
of spreading benign uterine tissue beyond the uterus during gynecologic
surgeries when LPMs are used. Parasitic myomas and disseminated
peritoneal leiomyomatosis, while benign, have been associated with the
need for additional surgery due to symptoms
[[Page 11094]]
such as abdominal pain and distension. Finally, FDA considered
additional available mitigations for the spread of uterine tissue.
Since 2014, FDA has provided marketing authorization for LPM
containment systems intended to isolate and contain tissue that is
considered benign. These products have been shown, through bench
testing and simulated use testing, to contain such tissue during
morcellation.
For these reasons, FDA is proposing in this draft guidance to
update its recommendations, as originally described in the 2014
guidance document, concerning the content and format of certain
labeling information for LPMs. Specifically, FDA is recommending that
manufacturers incorporate into the labeling for these devices
information providing greater specificity regarding the risks of use as
it relates to age, information regarding the risk of spreading benign
uterine tissue, and information regarding the use of LPM containment
systems.
FDA considered comments received on the final guidance document
that appeared in the Federal Register of November 25, 2014 (79 FR
70193). FDA revised the guidance as appropriate in response to the
comments.
II. Significance of Guidance
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 ``Product
Labeling for Laparoscopic Power Morcellators.'' 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.
III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Product Labeling for
Laparoscopic Power Morcellators'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1400052 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:
------------------------------------------------------------------------
OMB control
21 CFR part Topic No.
------------------------------------------------------------------------
807, subpart E.................... Premarket 0910-0120
notification.
800, 801, and 809................. Medical Device 0910-0485
Labeling
Regulations.
803............................... Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
reporting, importer
reporting, user
facility reporting,
distributor
reporting.
------------------------------------------------------------------------
Dated: February 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03827 Filed 2-25-20; 8:45 am]
BILLING CODE 4164-01-P