86570 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Section 105(b)(5) of the Child 

Abuse Prevention and Treatment Act 

(CAPTA) of 1978 (42 U.S.C. 5106(b)(5)), as 

amended by the CAPTA Reauthorization Act 

of 2010 (Pub. L. 111–320). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2020–28886 Filed 12–29–20; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1804] 

Product Labeling for Laparoscopic 

Power Morcellators; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Product Labeling for 

Laparoscopic Power Morcellators.’’ This 

guidance updates recommended 

‘‘Contraindications’’ and ‘‘Warnings’’ 

information to be included in product 

labeling to reflect the state of the science 

and available technology regarding use 

of laparoscopic power morcellators 

(LPMs). These labeling 

recommendations are intended to 

enhance, but not replace, the physicianpatient discussion of the benefits and 

risks of use of LPMs that uniquely 

pertain to individual patients. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 30, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–D–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, 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 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,’’ FDA 

has 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 

Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 86571 

when LPMs are used. Parasitic myomas 

and disseminated peritoneal 

leiomyomatosis, while benign, have 

been associated with the need for 

additional surgery due to symptoms 

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 updating 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. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of February 26, 2020 (85 FR 

11093). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including revisions to 

further discuss shared decision making 

that should occur between a physician 

and patient prior to undergoing the 

procedure, to elaborate on the benefits 

and risks of LPM containment systems, 

and to refine one of the sample warning 

statements. 

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 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. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Product Labeling 

for Laparoscopic Power Morcellators’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1400052 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations have been approved by OMB 

as listed in the following table: 

21 CFR part Topic OMB control 

No. 

807, subpart E ............... Premarket notification ............................................................................................................................. 0910–0120 

800, 801, and 809 .......... Medical Device Labeling Regulations ..................................................................................................... 0910–0485 

803 ................................. Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility 

reporting, distributor reporting.

0910–0437 

Dated: December 22, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28816 Filed 12–29–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3233] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Technical Electronic 

Product Radiation Safety Standards 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Technical Electronic 

Product Radiation Safety Standards 

Committee (TEPRSSC) in the Center for 

Devices and Radiological Health. 

Nominations will be accepted for 

current and upcoming vacancies 

effective with this notice. FDA seeks to 

include the views of women and men, 

members of all racial and ethnic groups, 

and individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before March 1, 2021, will be given first 

consideration for membership on 

TEPRSSC. Nominations received after 

March 1, 2021, will be considered for 

nomination to the committee as later 

vacancies occur. 

ADDRESSES: All nominations for 

membership should be sent 

electronically by logging into FDA’s 

Advisory Committee Membership 

Nomination Portal at https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Patricio G. Garcia, Division of 

Management Services, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5216, 

Silver Spring, MD 20993–0002, 301– 

796–6875, Patricio.Garcia@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members to serve on TEPRSSC that 

include five general public 

representatives and five government 

representatives.