
[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65359-65360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Technical Electronic Product Radiation Safety Standards 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Technical Electronic Product 
Radiation Safety Standards Committee. The general function of the 
committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on October 25, 2016, from 8:30 a.m. to 
5 p.m. and October 26, 2016, from 8:30 a.m. to 5 p.m.

ADDRESSES: Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village 
Ave., Gaithersburg, MD 20879. The hotel's telephone number is 301-948-
8900. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1643, Silver Spring, MD 20993-0002, 
sara.anderson@fda.hhs.gov, 301-796-7047, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The general function of the committee is to provide advice 
and recommendations to the Agency 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 Agency for consideration.
    On October 25, 2016, the committee will discuss and make 
recommendations regarding possible FDA performance standards for the 
following topics: Radiofrequency (RF) radiation products, such as 
microwave ovens and wireless power transfer; laser products, including 
an update to amendments to the laser rule, light detection and ranging 
(LIDAR), laser data (Light Fidelity-LiFi)/energy transfer, illumination 
applications and infrared applications; sunlamp products including an 
update on the performance standards amendments; and non-coherent light 
sources (e.g., LEDs and UVC lamps) including new initiatives.
    On October 26, 2016, the committee will discuss and make 
recommendations regarding possible FDA performance standards for the 
following topics: International Electrotechnical Commission (IEC) 
standards versus performance standards for medical devices; computed 
tomography (CT); radiography and fluoroscopy; diagnostic and 
therapeutic ultrasound; and radiation therapy.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the

[[Page 65360]]

appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
October 14, 2016. Oral presentations from the public will be scheduled 
between approximately 10 a.m. to 10:30 a.m. and 3 p.m. to 3:30 p.m. on 
October 25, 2016, and between approximately 10:15 a.m. to 10:45 a.m. 
and 2:30 p.m. to 3 p.m. on October 26, 2016. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before October 6, 2016. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by October 7, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at AnnMarie.Williams@fda.hhs.gov or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 16, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-22808 Filed 9-21-16; 8:45 am]
 BILLING CODE 4164-01-P


