Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 43440-43441 [2015-17985]

Download as PDF 43440 Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Notices Products with Environmental Attributes. Instructions: Please submit comments only and cite Information Collection 3090–0262, Identification of Products with Environmental Attributes, in all correspondence related to this collection. All comments received will be posted without change to http:// www.regulations.gov, including any personal and/or business confidential information provided. FOR FURTHER INFORMATION CONTACT: Ms. Dana Munson, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone 202–357– 9652 or via email to dana.munson@ gsa.gov. SUPPLEMENTARY INFORMATION: A. Purpose The General Services Administration (GSA) requires contractors holding Multiple Award Schedule Contracts to identify in their GSA price lists those products that they market commercially that have environmental attributes in accordance with GSAR clause 552.238– 72. The identification of these products will enable Federal agencies to maximize the use of these products and meet the responsibilities expressed in statutes and executive orders. tkelley on DSK3SPTVN1PROD with NOTICES B. Annual Reporting Burden Respondents: 9,000. Responses per Respondent: 1. Annual Responses: 9,000. Hours per Response: 1. Total Burden Hours: 9,000. C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202– 501–4755. Please cite OMB Control No. 3090–0262, Identification of Products with Environmental Attributes, in all correspondence. Dated: July 16, 2015. Jeffrey A. Koses, Senior Procurement Executive, Director, Office of Acquisition Policy. [FR Doc. 2015–17904 Filed 7–21–15; 8:45 am] BILLING CODE 6820–61–P VerDate Sep<11>2014 19:59 Jul 21, 2015 Jkt 235001 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 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/AboutAdvisory Committees/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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22JYN1.SGM 22JYN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Notices 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@ VerDate Sep<11>2014 19:59 Jul 21, 2015 Jkt 235001 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/AboutAdvisory Committees/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than August 21, 2015. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 594–4306. SUPPLEMENTARY INFORMATION: When submitting comments or requesting SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 43441 information, please include the information request collection title for reference. Information Collection Request Title: Providing Primary Care and Preventive Medical Services in Ryan White-funded Medical Care Settings: OMB No. 0915– XXXX—New. Abstract: Since Congress passed the Ryan White Comprehensive AIDS Resource Emergency (CARE) Act in 1990, the Ryan White HIV/AIDS Program (Ryan White Program) has funded the provision of care eligible to persons living with HIV (PLWH). Many Ryan White-funded clinics have long promoted the medical home model, which involves the provision of comprehensive and coordinated care services, including prevention and other non-medical care services to promote access and adherence to HIV/AIDS treatment. As PLWH live longer and normal lives with effective antiretroviral treatment, this model has become more complex. In recent years, clinics providing care to PLWH are also seeing their patients develop other common chronic diseases such as diabetes, heart disease, and hypertension associated with normal and aging populations. Guidelines 1 on primary care for PLWH have recently been released to help providers navigate the integration of primary and preventative care into HIV care. With already limited budgets, staffing and other resources, Ryan White-funded clinics may struggle to provide primary and preventative care services in-house or have insufficient referral systems. However, under the Affordable Care Act (ACA), most PLWH can obtain more affordable health insurance which can alleviate some burden on clinics and improve accessibility to primary and preventative care services. This study will examine how Ryan White-funded clinics are integrating the provision of primary and preventative care services to the overall HIV care model. Specifically, it will look at the protocols and strategies used by clinics to manage care for PLWH, specifically care coordination, referral systems, and patient-centered strategies to keep PLWH in care. 1 JA Aberg, JE Gallant, KG Ghanem, P Emmanuel, BS Zingman and MA Horberg. Primary Care Guidelines for the Management of Persons Infected with HIV: 2013 Update by the HIV Medicine Association of the Infectious Disease Society of America; CID 201_58 (January 1, 2014). New York State Department of Health AIDS Institute, Office of the Medical Director. Primary Care Approach to the HIV-Infected Patient; http:// www.hivguidelines.org/clinical-guidelines/adults/ primary-care-approach-to-the-hiv-infected-patient/ (Updated November 2014). E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Notices]
[Pages 43440-43441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

    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