Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 32964-32965 [2014-13290]

Download as PDF 32964 Federal Register / Vol. 79, No. 110 / Monday, June 9, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 21 U.S.C. Section 393(d)(2)(D) (various data collection methods) Number of responses per respondent Number of respondents Individual Indepth Interviews ............ General Public Focus Group Interviews. Intercept Interviews: Central Location. Intercept Interviews: Telephone ........ Self-Administered Surveys ................ Gatekeeper Reviews ......................... Omnibus Surveys .............................. Total annual responses Average burden per response Total hours 360 288 1 1 360 288 0.75 (45 minutes) ............................. 1.50 (90 minutes) ............................. 270 432 200 1 200 0.25 (15 minutes) ............................. 50 4,000 2,400 400 1,200 1 1 1 1 4,000 2,400 400 1,200 0.08 0.25 0.50 0.17 (5 minutes) ............................... (15 minutes) ............................. (30 minutes) ............................. (10 minutes) ............................. 320 600 200 204 Total (General Public) ................ Physician Focus Group Interviews ... 8,848 432 1 1 8,848 432 ........................................................... 1.50 (90 minutes) ............................. 2,076 648 Total (Physician) ........................ Total (Overall) ............................ 432 9,280 ........................ 1 ........................ 9,280 ........................................................... 0.29 (17 minutes) ............................. 648 2,724 Dated: June 3, 2014. Leslie Kux, Assistant Commissioner for Policy. control number 0910–0766. The approval expires on May 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. [FR Doc. 2014–13292 Filed 6–6–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: June 3, 2014. Leslie Kux, Assistant Commissioner for Policy. Food and Drug Administration [FR Doc. 2014–13291 Filed 6–6–14; 8:45 am] BILLING CODE 4160–01–P [Docket No. FDA–2010–D–0194] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Safety Assurance Case AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Safety Assurance Case’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: On April 10, 2014, the Agency submitted a proposed collection of information entitled ‘‘Safety Assurance Case’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB ehiers on DSK2VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 15:08 Jun 06, 2014 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0736] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on July 10 and 11, 2014, from 8 a.m. to 6 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–6639, 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 https:// 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. Agenda: On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations E:\FR\FM\09JNN1.SGM 09JNN1 ehiers on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 110 / Monday, June 9, 2014 / Notices (including the use of containment bags) for these devices. On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)). 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The Center for Devices and Radiological Health (CDRH) plans to provide a live webcast of the July 10 and 11, 2014, meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. While CDRH is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to reestablish the transmission as soon as possible. The link for the webcast is available at: https://colaboration.fda.gov/obgyd/, or further information regarding the webcast, including the Web address for the webcast, will be made available at least 2 days in advance of the meeting at the following Web site: https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/ MedicalDevices/ MedicalDevicesAdvisoryCommittee/ ObstetricsandGynecologyDevices/ default.htm. Select the link for 2014 Meeting Materials. 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 June 24, 2014. Oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m. for both days of this meeting. Those individuals interested in making formal oral presentations should VerDate Mar<15>2010 15:08 Jun 06, 2014 Jkt 232001 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 June 16, 2014. 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 June 19, 2014. FDA will work with the manufacturers of laparoscopic morcellators and containment bags who wish to make presentations to ensure that adequate time, separate from the approximate time slots for the general open public hearing session, is provided. Manufacturers interested in making formal presentations to the committee should notify the contact person on or before June 18, 2014. Manufacturers with common interests are urged to coordinate their oral presentations. FDA is opening a docket for public comment on this document. The docket number is FDA–2014–N–0736. The docket will close on August 11, 2014. Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting. Submit electronic comments to https://www.regulations.gov. Comments received on or before July 1, 2014, will be provided to the committee for their consideration. Comments received after July 1, 2014, will be taken into consideration by the Agency. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at https:// www.regulations.gov. 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 physical disabilities or special needs. If you PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 32965 require special 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 https://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: June 3, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–13290 Filed 6–6–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 18, 2014, Vol. #79, page 15133 and allowed 60days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. SUMMARY: E:\FR\FM\09JNN1.SGM 09JNN1

Agencies

[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32964-32965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0736]


Obstetrics and Gynecology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Obstetrics and Gynecology Devices Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 10 and 11, 2014, 
from 8 a.m. to 6 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Shanika Craig, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-6639, 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 https://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.
    Agenda: On July 10 and 11, 2014, the committee will discuss the 
safety of laparoscopic power morcellator devices as it pertains to 
their potential to disseminate and upstage a confined, but undetected 
(occult) uterine malignancy during laparoscopic hysterectomy or 
myomectomy. FDA is convening this committee to seek expert scientific 
and clinical opinion on the risks and benefits of these types of 
devices when used for these procedures, based on available scientific 
data. The committee will make recommendations regarding the appropriate 
use, premarket testing, labeling, and other risk mitigations

[[Page 32965]]

(including the use of containment bags) for these devices.
    On July 11, 2014, during the afternoon session, the committee will 
also be asked to discuss the regulatory classification of laparoscopic 
power morcellator devices when used to cut and extract tissue during 
gynecologic laparoscopic procedures and to assist FDA in determining 
the appropriate level of regulatory control necessary for this device 
type, including discussion of class II (special controls) or 
reclassification to class III (subject to premarket approval 
application (PMA)).
    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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    The Center for Devices and Radiological Health (CDRH) plans to 
provide a live webcast of the July 10 and 11, 2014, meeting of the 
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory 
Committee. While CDRH is working to make webcasts available to the 
public for all advisory committee meetings held at the White Oak 
campus, there are instances where the webcast transmission is not 
successful; staff will work to reestablish the transmission as soon as 
possible. The link for the webcast is available at: https://colaboration.fda.gov/obgyd/, or further information regarding the 
webcast, including the Web address for the webcast, will be made 
available at least 2 days in advance of the meeting at the following 
Web site: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/default.htm. Select the link for 2014 Meeting Materials.
    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 June 
24, 2014. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 a.m. for both days of this meeting. 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 June 
16, 2014. 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 June 19, 2014.
    FDA will work with the manufacturers of laparoscopic morcellators 
and containment bags who wish to make presentations to ensure that 
adequate time, separate from the approximate time slots for the general 
open public hearing session, is provided. Manufacturers interested in 
making formal presentations to the committee should notify the contact 
person on or before June 18, 2014. Manufacturers with common interests 
are urged to coordinate their oral presentations.
    FDA is opening a docket for public comment on this document. The 
docket number is FDA-2014-N-0736. The docket will close on August 11, 
2014. Interested persons are encouraged to use the docket to submit 
electronic or written comments regarding this meeting. Submit 
electronic comments to https://www.regulations.gov. Comments received on 
or before July 1, 2014, will be provided to the committee for their 
consideration. Comments received after July 1, 2014, will be taken into 
consideration by the Agency.
    Submit written comments to the Division of Dockets Management, Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. It is only necessary to send one set of comments. Comments are 
to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the 
Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday and will be posted to the docket at https://www.regulations.gov.
    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 
physical disabilities or special needs. If you require special 
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 https://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: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13290 Filed 6-6-14; 8:45 am]
BILLING CODE 4160-01-P

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