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. 

86572 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 

I. General Description of the 

Committee’s Duties 

The committee provides advice and 

consultation to the Commissioner of 

Food and Drugs (the Commissioner) on 

the technical feasibility, reasonableness, 

and practicability of performance 

standards for electronic products to 

control the emission of radiation from 

such products, and may recommend 

electronic product radiation safety 

standards to the Commissioner for 

consideration. 

II. Criteria for Voting Members 

The committee consists of a core of 15 

voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among authorities knowledgeable in the 

fields of science or engineering, 

applicable to electronic product 

radiation safety. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Terms of more than 2 

years are contingent upon the renewal 

of the committee by appropriate action 

prior to its expiration. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the committee. Selfnominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address and/or home address, 

telephone number, and email address if 

available and a signed copy of the 

Acknowledgement and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 22, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28833 Filed 12–29–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Advancing Translational Sciences Special 

Emphasis Panel; SBIR Contract Review Topic 

20. 

Date: January 12, 2021. 

Time: 12:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

1078, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Rahat (Rani) Khan, Ph.D. 

Scientific Review Officer, Office of Scientific 

Review, National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

1078 Bethesda, MD 20892, 301–594–7319 

khanr2@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: December 22, 2020. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–28842 Filed 12–29–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development Initial 

Review Group; Health, Behavior, and Context 

Subcommittee. 

Date: February 22, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NICHD/NIH, 6710B Rockledge 

Drive, Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Kimberly L. Houston, 

M.D., Scientific Review Officer, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, 6701B 

Rockledge Drive, Room 2137C, Bethesda, MD 

20892, 301–827–4902, kimberly.houston@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: December 23, 2020. 

Ronald J. Livingston, Jr., 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–28841 Filed 12–29–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings.