Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee, 86571-86572 [2020-28833]

Download as PDF Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 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 A notice of availability of the draft guidance appeared in the Federal Register of February 26, 2020 (85 FR 11093).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-comprehensive- regulatory-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: OMB control No. 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: 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. The Food and Drug Administration (FDA) is requesting nominations for voting members to SUMMARY: VerDate Sep<11>2014 17:47 Dec 29, 2020 Jkt 253001 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:// PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 86571 0910–0120 0910–0485 0910–0437 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. E:\FR\FM\30DEN1.SGM 30DEN1 86572 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices I. General Description of the Committee’s Duties DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. National Institutes of Health National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting 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 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. 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. 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. 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] Jkt 253001 [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. BILLING CODE 4164–01–P 17:47 Dec 29, 2020 Dated: December 23, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P [FR Doc. 2020–28833 Filed 12–29–20; 8:45 am] VerDate Sep<11>2014 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) PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86571-86572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28833]


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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, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members to serve on TEPRSSC that include five general public 
representatives and five government representatives.

[[Page 86572]]

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. Self-nominations are also 
accepted. Nominations must include a current, complete 
r[eacute]sum[eacute] 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

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