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

when LPMs are used. Parasitic myomas Register of February 26, 2020 (85 FR regulatory-assistance/guidance- and disseminated peritoneal 11093). FDA considered comments documents-medical-devices-and- leiomyomatosis, while benign, have received and revised the guidance as radiation-emitting-products. This been associated with the need for appropriate in response to the guidance document is also available at additional surgery due to symptoms comments, including revisions to https://www.regulations.gov and at such as abdominal pain and distension. further discuss shared decision making https://www.fda.gov/regulatory- Finally, FDA considered additional that should occur between a physician information/search-fda-guidance- available mitigations for the spread of and patient prior to undergoing the documents. Persons unable to download uterine tissue. Since 2014, FDA has procedure, to elaborate on the benefits an electronic copy of ‘‘Product Labeling provided marketing authorization for and risks of LPM containment systems, for Laparoscopic Power Morcellators’’ LPM containment systems intended to and to refine one of the sample warning may send an email request to CDRH- isolate and contain tissue that is statements. [email protected] to receive an considered benign. These products have This guidance is being issued electronic copy of the document. Please been shown, through bench testing and consistent with FDA’s good guidance use the document number 1400052 and simulated use testing, to contain such practices regulation (21 CFR 10.115). complete title to identify the guidance tissue during morcellation. The guidance represents the current you are requesting. thinking of FDA on product labeling for For these reasons, FDA is updating its laparoscopic power morcellators. It does III. Paperwork Reduction Act of 1995 recommendations, as originally not establish any rights for any person described in the 2014 guidance and is not binding on FDA or the public. While this guidance contains no document, concerning the content and You can use an alternative approach if collection of information, it does refer to format of certain labeling information it satisfies the requirements of the previously approved FDA collections of for LPMs. Specifically, FDA is applicable statutes and regulations. information. Therefore, clearance by the recommending that manufacturers Office of Management and Budget incorporate into the labeling for these II. Electronic Access (OMB) under the Paperwork Reduction devices information providing greater Persons interested in obtaining a copy Act of 1995 (PRA) (44 U.S.C. 3501– specificity regarding the risks of use as of the guidance may do so by 3521) is not required for this guidance. it relates to age, information regarding downloading an electronic copy from The previously approved collections of the risk of spreading benign uterine the internet. A search capability for all information are subject to review by tissue, and information regarding the Center for Devices and Radiological OMB under the PRA. The collections of use of LPM containment systems. Health guidance documents is available information in the following FDA A notice of availability of the draft at https://www.fda.gov/medical-devices/ regulations have been approved by OMB guidance appeared in the Federal device-advice-comprehensive- as listed in the following table:

OMB control 21 CFR part Topic 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 0910–0437 reporting, distributor reporting.

Dated: December 22, 2020. serve on the Technical Electronic www.accessdata.fda.gov/scripts/ Lauren K. Roth, Product Radiation Safety Standards FACTRSPortal/FACTRS/index.cfm or by Acting Principal Associate Commissioner for Committee (TEPRSSC) in the Center for mail to Advisory Committee Oversight Policy. Devices and Radiological Health. and Management Staff, Food and Drug [FR Doc. 2020–28816 Filed 12–29–20; 8:45 am] Nominations will be accepted for Administration, 10903 New Hampshire BILLING CODE 4164–01–P current and upcoming vacancies Ave., Bldg. 32, Rm. 5103, Silver Spring, effective with this notice. FDA seeks to MD 20993–0002. Information about include the views of women and men, becoming a member on an FDA advisory DEPARTMENT OF HEALTH AND members of all racial and ethnic groups, committee can also be obtained by HUMAN SERVICES and individuals with and without visiting FDA’s website at https:// disabilities on its advisory committees www.fda.gov/AdvisoryCommittees/ Food and Drug Administration and, therefore, encourages nominations default.htm. [Docket No. FDA–2018–N–3233] of appropriately qualified candidates FOR FURTHER INFORMATION CONTACT: from these groups. Patricio G. Garcia, Division of Request for Nominations for Voting DATES: Nominations received on or Management Services, Center for Members on a Public Advisory before March 1, 2021, will be given first Devices and Radiological Health, Food Committee; Technical Electronic consideration for membership on and Drug Administration, 10903 New Product Radiation Safety Standards TEPRSSC. Nominations received after Hampshire Ave., Bldg. 66, Rm. 5216, Committee March 1, 2021, will be considered for Silver Spring, MD 20993–0002, 301– AGENCY: Food and Drug Administration, nomination to the committee as later 796–6875, [email protected]. HHS. vacancies occur. SUPPLEMENTARY INFORMATION: FDA is ACTION: Notice. ADDRESSES: All nominations for requesting nominations for voting membership should be sent members to serve on TEPRSSC that SUMMARY: The Food and Drug electronically by logging into FDA’s include five general public Administration (FDA) is requesting Advisory Committee Membership representatives and five government nominations for voting members to Nomination Portal at https:// representatives.

VerDate Sep<11>2014 17:47 Dec 29, 2020 Jkt 253001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1 86572 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices

I. General Description of the DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Committee’s Duties HUMAN SERVICES HUMAN SERVICES

The committee provides advice and National Institutes of Health National Institutes of Health consultation to the Commissioner of Food and Drugs (the Commissioner) on National Center for Advancing Eunice Kennedy Shriver National the technical feasibility, reasonableness, Translational Sciences; Notice of Institute of Child Health & Human and practicability of performance Closed Meeting Development; Notice of Closed standards for electronic products to Meeting control the emission of radiation from Pursuant to section 10(d) of the Pursuant to section 10(d) of the such products, and may recommend Federal Advisory Committee Act, as Federal Advisory Committee Act, as electronic product radiation safety amended, notice is hereby given of the amended, notice is hereby given of the standards to the Commissioner for following meeting. following meeting. consideration. The meeting will be closed to the The meeting will be closed to the II. Criteria for Voting Members public in accordance with the public in accordance with the provisions set forth in sections provisions set forth in sections The committee consists of a core of 15 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., voting members including the Chair. as amended. The contract proposals and as amended. The grant applications and Members and the Chair are selected by the discussions could disclose the discussions could disclose the Commissioner or designee from confidential trade secrets or commercial confidential trade secrets or commercial among authorities knowledgeable in the property such as patentable material, property such as patentable material, fields of science or engineering, and personal information concerning and personal information concerning applicable to electronic product individuals associated with the contract individuals associated with the grant radiation safety. Members will be proposals, the disclosure of which applications, the disclosure of which invited to serve for overlapping terms of would constitute a clearly unwarranted would constitute a clearly unwarranted up to 4 years. Terms of more than 2 invasion of personal privacy. invasion of personal privacy. years are contingent upon the renewal Name of Committee: National Institute of of the committee by appropriate action Name of Committee: National Center for Child Health and Human Development Initial prior to its expiration. Advancing Translational Sciences Special Review Group; Health, Behavior, and Context Emphasis Panel; SBIR Contract Review Topic Subcommittee. III. Nomination Procedures 20. Date: February 22, 2021. Date: January 12, 2021. Time: 10:00 a.m. to 5:00 p.m. Any interested person may nominate Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant one or more qualified individuals for Agenda: To review and evaluate contract applications. membership on the committee. Self- proposals. Place: NICHD/NIH, 6710B Rockledge nominations are also accepted. Place: National Center for Advancing Drive, Bethesda, MD 20892 (Virtual Meeting). Nominations must include a current, Translational Sciences, National Institutes of Contact Person: Kimberly L. Houston, M.D., Scientific Review Officer, Eunice complete re´sume´ or curriculum vitae for Health, 6701 Democracy Boulevard, Room Kennedy Shriver National Institute of Child each nominee, including current 1078, Bethesda, MD 20892 (Virtual Meeting). business address and/or home address, Health and Human Development, 6701B Contact Person: Rahat (Rani) Khan, Ph.D. Rockledge Drive, Room 2137C, Bethesda, MD telephone number, and email address if Scientific Review Officer, Office of Scientific 20892, 301–827–4902, kimberly.houston@ available and a signed copy of the Review, National Center for Advancing nih.gov. Acknowledgement and Consent form Translational Sciences, National Institutes of (Catalogue of Federal Domestic Assistance available at the FDA Advisory Health, 6701 Democracy Boulevard, Room Program Nos. 93.864, Population Research; Nomination Portal (see ADDRESSES). 1078 Bethesda, MD 20892, 301–594–7319 93.865, Research for Mothers and Children; Nominations must also specify the [email protected]. 93.929, Center for Medical Rehabilitation advisory committee for which the This notice is being published less than 15 Research; 93.209, Contraception and nominee is recommended. Nominations days prior to the meeting due to the timing Infertility Loan Repayment Program, National Institutes of Health, HHS) must also acknowledge that the limitations imposed by the review and nominee is aware of the nomination funding cycle. Dated: December 23, 2020. unless self-nominated. FDA will ask (Catalogue of Federal Domestic Assistance Ronald J. Livingston, Jr., potential candidates to provide detailed Program Nos. 93.859, Pharmacology, Program Analyst, Office of Federal Advisory information concerning such matters Physiology, and Biological Chemistry Committee Policy. related to financial holdings, Research; 93.350, B—Cooperative [FR Doc. 2020–28841 Filed 12–29–20; 8:45 am] employment, and research grants and/or Agreements; 93.859, Biomedical Research BILLING CODE 4140–01–P contracts to permit evaluation of and Research Training, National Institutes of possible sources of conflicts of interest. Health, HHS) This notice is issued under the DEPARTMENT OF HEALTH AND Federal Advisory Committee Act (5 Dated: December 22, 2020. HUMAN SERVICES U.S.C. app. 2) and 21 CFR part 14, David W. Freeman, National Institutes of Health relating to advisory committees. Program Analyst, Office of Federal Advisory Committee Policy. Dated: December 22, 2020. National Cancer Institute; Notice of [FR Doc. 2020–28842 Filed 12–29–20; 8:45 am] Lauren K. Roth, Closed Meetings BILLING CODE 4140–01–P Acting Principal Associate Commissioner for Pursuant to section 10(d) of the Policy. Federal Advisory Committee Act, as [FR Doc. 2020–28833 Filed 12–29–20; 8:45 am] amended, notice is hereby given of the BILLING CODE 4164–01–P following meetings.

VerDate Sep<11>2014 17:47 Dec 29, 2020 Jkt 253001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1