Product Labeling for Laparoscopic Power Morcellators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 11093-11094 [2020-03827]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Food and Drug Administration [Docket No. FDA–2014–D–1804] Product Labeling for Laparoscopic Power Morcellators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Product Labeling for Laparoscopic Power Morcellators.’’ This draft guidance proposes updated ‘‘Contraindications’’ and ‘‘Warnings’’ in product labeling information to reflect the state of the science and available technology regarding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 This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by April 27, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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


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