80_FR_43580 80 FR 43440 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

80 FR 43440 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 140 (July 22, 2015)

Page Range43440-43441
FR Document2015-17985

Federal Register, Volume 80 Issue 140 (Wednesday, July 22, 2015) 
[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Notices]
[Pages 43440-43441]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17985]


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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.

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    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 September 24, 2015, from 
8 a.m. to 6 p.m.

ADDRESSES: FDA is opening a docket for interested persons to submit 
electronic or written comments regarding this meeting. The docket 
number is FDA-2014-N-0736. Please see the Procedure section of the 
notice for further information.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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.
    Contact Person: Shanika Craig, Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-6639, Shanika.Craig@fda.hhs.gov, 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.
    Agenda: On September 24, 2015, the committee will discuss the risks 
and benefits of Bayer HealthCare's Essure System for permanent female 
sterilization. The system, originally approved in November 2002, under 
P020014, consists of a delivery system and nickel-containing permanent 
implants. The implants are placed without a skin incision, through the 
vagina, within each fallopian tube; they elicit tissue ingrowth, which 
over time results in tubal occlusion.
    FDA is convening this committee to seek expert scientific and 
clinical opinion on the risks and benefits of the Essure System. The 
committee will be asked to evaluate currently available scientific data 
pertaining to the safety and effectiveness of the Essure System, such 
as events related to implant perforation/migration, device removal, 
chronic pain, allergic reactions, and unintended pregnancy. The 
committee will be asked to provide recommendations regarding 
appropriate device use, product labeling, and potential need for 
additional postmarket clinical studies.
    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 appropriate advisory committee meeting 
link.
    CDRH plans to provide a live Webcast of the September 24, 2015, 
meeting of the Obstetrics and Gynecology Devices Panel. 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 
re-establish the transmission as soon as possible. The link for the 
Webcast is available at: https://collaboration.fda.gov/gudpm052015/. 
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://collaboration.fda.gov/ogdp2015/.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending

[[Page 43441]]

before the committee. Written submissions may be made to the contact 
person on or before September 4, 2015. Oral presentations from the 
public will be scheduled between approximately 9 a.m. and 10 a.m. on 
September 24, 2015. 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 August 24, 2015. 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 August 
28, 2015.
    FDA is opening a docket for public comment on this document. The 
docket will close on October 24, 2015. Interested persons are 
encouraged to use the docket to submit electronic or written comments 
regarding this meeting. Comments received on or before August 31, 2015, 
will be provided to the committee. Comments received after that date 
will be taken into consideration by the Agency.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit a single copy of electronic comments or two paper copies of any 
mailed 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 http://www.regulations.gov.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    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 Ann Marie 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: July 17, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-17985 Filed 7-21-15; 8:45 am]
BILLING CODE 4164-01-P

43440 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Notices Products with Environmental DEPARTMENT OF HEALTH AND modifications before coming to the Attributes. HUMAN SERVICES meeting. Instructions: Please submit comments Agenda: On September 24, 2015, the only and cite Information Collection Food and Drug Administration committee will discuss the risks and 3090–0262, Identification of Products benefits of Bayer HealthCare’s Essure with Environmental Attributes, in all [Docket No. FDA–2014–N–0736] System for permanent female correspondence related to this sterilization. The system, originally Obstetrics and Gynecology Devices approved in November 2002, under collection. All comments received will Panel of the Medical Devices Advisory P020014, consists of a delivery system be posted without change to http:// Committee; Notice of Meeting and nickel-containing permanent www.regulations.gov, including any personal and/or business confidential AGENCY: Food and Drug Administration, implants. The implants are placed information provided. HHS. without a skin incision, through the FOR FURTHER INFORMATION CONTACT: Ms. vagina, within each fallopian tube; they ACTION: Notice. Dana Munson, Procurement Analyst, elicit tissue ingrowth, which over time General Services Acquisition Policy This notice announces a forthcoming results in tubal occlusion. Division, GSA, at telephone 202–357– meeting of a public advisory committee FDA is convening this committee to 9652 or via email to dana.munson@ of the Food and Drug Administration seek expert scientific and clinical gsa.gov. (FDA). The meeting will be open to the opinion on the risks and benefits of the public. Essure System. The committee will be SUPPLEMENTARY INFORMATION: asked to evaluate currently available Name of Committee: Obstetrics and A. Purpose Gynecology Devices Panel of the scientific data pertaining to the safety Medical Devices Advisory Committee. and effectiveness of the Essure System, The General Services Administration such as events related to implant (GSA) requires contractors holding General Function of the Committee: To provide advice and perforation/migration, device removal, Multiple Award Schedule Contracts to chronic pain, allergic reactions, and identify in their GSA price lists those recommendations to the Agency on FDA’s regulatory issues. unintended pregnancy. The committee products that they market commercially will be asked to provide that have environmental attributes in Date and Time: The meeting will be held on September 24, 2015, from 8 a.m. recommendations regarding appropriate accordance with GSAR clause 552.238– device use, product labeling, and 72. The identification of these products to 6 p.m. potential need for additional postmarket will enable Federal agencies to ADDRESSES: FDA is opening a docket for clinical studies. maximize the use of these products and interested persons to submit electronic FDA intends to make background meet the responsibilities expressed in or written comments regarding this material available to the public no later statutes and executive orders. meeting. The docket number is FDA– than 2 business days before the meeting. 2014–N–0736. Please see the Procedure If FDA is unable to post the background B. Annual Reporting Burden section of the notice for further material on its Web site prior to the Respondents: 9,000. information. meeting, the background material will Responses per Respondent: 1. Location: FDA White Oak Campus, be made publicly available at the Annual Responses: 9,000. 10903 New Hampshire Ave., Bldg. 31 location of the advisory committee Hours per Response: 1. Conference Center, the Great Room (Rm. Total Burden Hours: 9,000. meeting, and the background material 1503), Silver Spring, MD 20993–0002. will be posted on FDA’s Web site after C. Public Comments Answers to commonly asked questions the meeting. Background material is including information regarding special available at http://www.fda.gov/ Public comments are particularly accommodations due to a disability, AdvisoryCommittees/Calendar/ invited on: Whether this collection of visitor parking, and transportation may default.htm. Scroll down to the information is necessary and whether it be accessed at: http://www.fda.gov/ appropriate advisory committee meeting will have practical utility; whether our AdvisoryCommittees/AboutAdvisory link. estimate of the public burden of this Committees/ucm408555.htm. CDRH plans to provide a live Webcast collection of information is accurate and Contact Person: Shanika Craig, Center of the September 24, 2015, meeting of based on valid assumptions and for Devices and Radiological Health the Obstetrics and Gynecology Devices methodology; and ways to enhance the (CDRH), Food and Drug Administration, Panel. While CDRH is working to make quality, utility, and clarity of the 10903 New Hampshire Ave., Silver Webcasts available to the public for all information to be collected. Obtaining Copies of Proposals: Spring, MD 20993, 301–796–6639, advisory committee meetings held at the Requesters may obtain a copy of the Shanika.Craig@fda.hhs.gov, or FDA White Oak campus, there are instances information collection documents from Advisory Committee Information Line, where the Webcast transmission is not the Regulatory Secretariat Division 1–800–741–8138 (301–443–0572 in the successful; staff will work to re-establish (MVCB), 1800 F Street NW., Washington, DC area). A notice in the the transmission as soon as possible. Washington, DC 20405, telephone 202– Federal Register about last minute The link for the Webcast is available at: 501–4755. Please cite OMB Control No. modifications that impact a previously https://collaboration.fda.gov/ 3090–0262, Identification of Products announced advisory committee meeting gudpm052015/. Further information with Environmental Attributes, in all cannot always be published quickly regarding the Webcast, including the correspondence. enough to provide timely notice. Web address for the Webcast, will be tkelley on DSK3SPTVN1PROD with NOTICES Therefore, you should always check the made available at least 2 days in Dated: July 16, 2015. Agency’s Web site at http:// advance of the meeting at the following Jeffrey A. Koses, www.fda.gov/AdvisoryCommittees/ Web site: https://collaboration.fda.gov/ Senior Procurement Executive, Director, default.htm and scroll down to the ogdp2015/. Office of Acquisition Policy. appropriate advisory committee meeting Procedure: Interested persons may [FR Doc. 2015–17904 Filed 7–21–15; 8:45 am] link, or call the advisory committee present data, information, or views, BILLING CODE 6820–61–P information line to learn about possible orally or in writing, on issues pending VerDate Sep<11>2014 19:59 Jul 21, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1

Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Notices 43441 before the committee. Written fda.hhs.gov or 301–796–5966 at least 7 information, please include the submissions may be made to the contact days in advance of the meeting. information request collection title for person on or before September 4, 2015. FDA is committed to the orderly reference. Oral presentations from the public will conduct of its advisory committee Information Collection Request Title: be scheduled between approximately 9 meetings. Please visit our Web site at Providing Primary Care and Preventive a.m. and 10 a.m. on September 24, 2015. http://www.fda.gov/ Medical Services in Ryan White-funded Those individuals interested in making AdvisoryCommittees/AboutAdvisory Medical Care Settings: OMB No. 0915– formal oral presentations should notify Committees/ucm111462.htm for XXXX—New. the contact person and submit a brief procedures on public conduct during Abstract: Since Congress passed the statement of the general nature of the advisory committee meetings. Ryan White Comprehensive AIDS evidence or arguments they wish to Notice of this meeting is given under Resource Emergency (CARE) Act in present, the names and addresses of the Federal Advisory Committee Act (5 1990, the Ryan White HIV/AIDS proposed participants, and an U.S.C. app. 2). Program (Ryan White Program) has indication of the approximate time Dated: July 17, 2015. funded the provision of care eligible to requested to make their presentation on persons living with HIV (PLWH). Many Jill Hartzler Warner, or before August 24, 2015. Time allotted Ryan White-funded clinics have long for each presentation may be limited. If Associate Commissioner for Special Medical Programs. promoted the medical home model, the number of registrants requesting to which involves the provision of [FR Doc. 2015–17985 Filed 7–21–15; 8:45 am] speak is greater than can be reasonably comprehensive and coordinated care accommodated during the scheduled BILLING CODE 4164–01–P services, including prevention and other open public hearing session, FDA may non-medical care services to promote conduct a lottery to determine the access and adherence to HIV/AIDS speakers for the scheduled open public DEPARTMENT OF HEALTH AND HUMAN SERVICES treatment. As PLWH live longer and hearing session. The contact person will normal lives with effective antiretroviral notify interested persons regarding their Health Resources and Services treatment, this model has become more request to speak by August 28, 2015. Administration complex. In recent years, clinics FDA is opening a docket for public providing care to PLWH are also seeing comment on this document. The docket Agency Information Collection their patients develop other common will close on October 24, 2015. Activities: Proposed Collection: Public chronic diseases such as diabetes, heart Interested persons are encouraged to use Comment Request disease, and hypertension associated the docket to submit electronic or AGENCY: Health Resources and Services with normal and aging populations. written comments regarding this Administration, Department of Health Guidelines 1 on primary care for PLWH meeting. Comments received on or and Human Services. have recently been released to help before August 31, 2015, will be providers navigate the integration of provided to the committee. Comments ACTION: Notice. received after that date will be taken primary and preventative care into HIV into consideration by the Agency. SUMMARY: In compliance with the care. With already limited budgets, Submit electronic comments to http:// requirement for opportunity for public staffing and other resources, Ryan www.regulations.gov. Submit written comment on proposed data collection White-funded clinics may struggle to comments to the Division of Dockets projects (section 3506(c)(2)(A) of the provide primary and preventative care Management, Food and Drug Paperwork Reduction Act of 1995), the services in-house or have insufficient Administration, 5630 Fishers Lane, rm. Health Resources and Services referral systems. However, under the 1061, Rockville, MD 20852. Submit a Administration (HRSA) announces Affordable Care Act (ACA), most PLWH single copy of electronic comments or plans to submit an Information can obtain more affordable health two paper copies of any mailed Collection Request (ICR), described insurance which can alleviate some comments. Comments are to be below, to the Office of Management and burden on clinics and improve identified with the docket number Budget (OMB). Prior to submitting the accessibility to primary and found in brackets in the heading of this ICR to OMB, HRSA seeks comments preventative care services. document. Received comments may be from the public regarding the burden This study will examine how Ryan seen in the Divisions of Dockets estimate, below, or any other aspect of White-funded clinics are integrating the Management between 9 a.m. and 4 p.m., the ICR. provision of primary and preventative Monday through Friday, and will be DATES: Comments on this Information care services to the overall HIV care posted to the docket at http:// Collection Request must be received no model. Specifically, it will look at the www.regulations.gov. later than August 21, 2015. protocols and strategies used by clinics For press inquiries, please contact the to manage care for PLWH, specifically ADDRESSES: Submit your comments, Office of Media Affairs at fdaoma@ care coordination, referral systems, and including the Information Collection patient-centered strategies to keep fda.hhs.gov or 301–796–4540. Request Title, to the desk officer for PLWH in care. Persons attending FDA’s advisory HRSA, either by email to OIRA_ committee meetings are advised that the submission@omb.eop.gov or by fax to Agency is not responsible for providing 1 JA Aberg, JE Gallant, KG Ghanem, P Emmanuel, 202–395–5806. BS Zingman and MA Horberg. Primary Care access to electrical outlets. FDA welcomes the attendance of the FOR FURTHER INFORMATION CONTACT: To Guidelines for the Management of Persons Infected request a copy of the clearance requests with HIV: 2013 Update by the HIV Medicine tkelley on DSK3SPTVN1PROD with NOTICES public at its advisory committee Association of the Infectious Disease Society of meetings and will make every effort to submitted to OMB for review, email the America; CID 201_58 (January 1, 2014). accommodate persons with physical HRSA Information Collection Clearance New York State Department of Health AIDS disabilities or special needs. If you Officer at paperwork@hrsa.gov or call Institute, Office of the Medical Director. Primary (301) 594–4306. Care Approach to the HIV-Infected Patient; http:// require special accommodations due to www.hivguidelines.org/clinical-guidelines/adults/ a disability, please contact Ann Marie SUPPLEMENTARY INFORMATION: When primary-care-approach-to-the-hiv-infected-patient/ Williams, at AnnMarie.Williams@ submitting comments or requesting (Updated November 2014). VerDate Sep<11>2014 19:59 Jul 21, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1


Document Created: 2015-12-15 12:54:57
Document Modified: 2015-12-15 12:54:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 43440 
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