80 FR 13395 - Gastroenterology and Urology 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 49 (March 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 49 (March 13, 2015)
| Page Range | 13395-13396 | |
| FR Document | 2015-05710 |
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)] [Notices] [Pages 13395-13396] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05710] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0722] Gastroenterology and Urology 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: Gastroenterology and Urology 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 May 14 and 15, 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 No. is FDA-2015-N-0722. 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: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993-0002, 301-796-5290, Natasha.Facey@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 May 14 and 15, 2015, the committee will discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States. FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information. The committee will make recommendations on: (1) The effectiveness of cleaning, high level disinfection, and sterilization methods; (2) the amount and type of premarket validation data and information needed to support labeling claims and technical instructions; (3) the appropriate use of other risk mitigations, such as surveillance cultures; (4) best practices and guidelines for reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections; and (5) recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection. Recommendations on these issues will assist FDA in minimizing patient exposure to infectious agents that may result from reprocessed duodenoscopes and endoscopes. 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 May 14 and 15, 2015, meeting of the Gastroenterology and Urology 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/. [[Page 13396]] 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: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/default.htm. Select the link for 2015 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 April 30, 2015. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on May 14 and between approximately 9 a.m. and 10 a.m. on May 15. 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 April 15, 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 April 20, 2015. FDA is opening a docket for public comment on this document. The Docket No. is FDA-2015-N-0722. The docket will close on May 28, 2015. Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting. Comments received on or before April 30, 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 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: March 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-05710 Filed 3-12-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices 13395
should be from individuals who are not DEPARTMENT OF HEALTH AND to learn about possible modifications
part of the organization. HUMAN SERVICES before coming to the meeting.
(3) A statement that the organization Agenda: On May 14 and 15, 2015, the
is willing to serve as a non-voting Food and Drug Administration committee will discuss recent reports
liaison representative of the Committee and epidemiologic investigations of
and will cover expenses for their [Docket No. FDA–2015–N–0722] transmission of infections associated
with the use of duodenoscopes in
representative to attend in-person, at a Gastroenterology and Urology Devices endoscopic retrograde
minimum, one CFSAC meeting per year Panel of the Medical Devices Advisory cholangiopancreatography (ERCP)
in Washington, DC, during the Committee; Notice of Meeting procedures in hospitals in the United
designated term of appointment.
AGENCY: Food and Drug Administration, States.
(4) A current financial disclosure FDA is convening this committee to
statement (or annual report) HHS.
seek expert scientific and clinical
demonstrating the organization’s ability ACTION: Notice. opinion related to reprocessing of
to cover expenses for its selected duodenoscopes and other endoscopes,
representative to attend, at a minimum, This notice announces a forthcoming
as well as automated endoscope
one CFSAC meeting per year in meeting of a public advisory committee
reprocessors, based on available
Washington, DC, during the term of of the Food and Drug Administration
scientific information. The committee
appointment. (FDA). The meeting will be open to the
will make recommendations on: (1) The
public.
Submitted nominations must include effectiveness of cleaning, high level
Name of Committee: Gastroenterology
these critical elements in order for the disinfection, and sterilization methods;
and Urology Devices Panel of the (2) the amount and type of premarket
organization to be considered for one of Medical Devices Advisory Committee.
the liaison representative positions. validation data and information needed
General Function of the Committee: to support labeling claims and technical
Nomination materials should be To provide advice and instructions; (3) the appropriate use of
typewritten, using a 12-point font and recommendations to the Agency on other risk mitigations, such as
double-spaced. All nomination FDA’s regulatory issues. surveillance cultures; (4) best practices
materials should be submitted Date and Time: The meeting will be and guidelines for reprocessing
(postmarked or received) by April 20, held on May 14 and 15, 2015, from 8 duodenoscopes and endoscopes at user
2015. a.m. to 6 p.m. facilities to minimize the transmission
Electronic submissions: Nomination Addresses: FDA is opening a docket of infections; and (5) recommended
materials, including attachments, may for interested persons to submit approaches for ensuring patient safety
be submitted electronically to cfsac@ electronic or written comments during ERCP procedures, including a
hhs.gov. regarding this meeting. The Docket No. discussion of appropriate patient
is FDA–2015–N–0722. Please see the selection.
Telephone and facsimile submissions Procedure section of the notice for Recommendations on these issues
cannot be accepted. further information. will assist FDA in minimizing patient
Regular, Express or Overnight Mail: Location: FDA White Oak Campus, exposure to infectious agents that may
Written documents may be submitted to 10903 New Hampshire Ave., Bldg. 31 result from reprocessed duodenoscopes
the following addressee only: Barbara F. Conference Center, the Great Room (Rm. and endoscopes.
James, Designated Federal Officer, 1503), Silver Spring, MD 20993–0002. FDA intends to make background
CFSAC, Office on Women’s Health, Answers to commonly asked questions material available to the public no later
Department of Health and Human including information regarding special than 2 business days before the meeting.
Services, 200 Independence Avenue accommodations due to a disability, If FDA is unable to post the background
SW., Room 728F.3, Washington, DC visitor parking, and transportation may material on its Web site prior to the
20201. be accessed at: http://www.fda.gov/ meeting, the background material will
HHS makes every effort to ensure that AdvisoryCommittees/AboutAdvisory be made publicly available at the
the membership of federal advisory Committees/ucm408555.htm. location of the advisory committee
committees is fairly balanced in terms of Contact Person: Natasha Facey, Center meeting, and the background material
points of view represented. Every effort for Devices and Radiological Health, will be posted on FDA’s Web site after
is made to ensure that a broad Food and Drug Administration, 10903 the meeting. Background material is
representation of geographic areas, sex, New Hampshire Ave., Bldg. 66, Rm. available at http://www.fda.gov/
ethnic and minority groups, and people 1552, Silver Spring, MD 20993–0002, AdvisoryCommittees/Calendar/
with disabilities are given consideration 301–796–5290, Natasha.Facey@ default.htm. Scroll down to the
for membership on federal advisory fda.hhs.gov, or FDA Advisory appropriate advisory committee meeting
committees. Selection of the represented Committee Information Line, 1–800– link.
organizations shall be made without 741–8138 (301–443–0572 in the CDRH plans to provide a live Webcast
discrimination against the composition Washington, DC area). A notice in the of the May 14 and 15, 2015, meeting of
of an organization’s membership on the Federal Register about last minute the Gastroenterology and Urology
basis of age, sex, race, ethnicity, sexual modifications that impact a previously Devices Panel. While CDRH is working
orientation, disability, and cultural, announced advisory committee meeting to make Webcasts available to the public
mstockstill on DSK4VPTVN1PROD with NOTICES
religious, or socioeconomic status. cannot always be published quickly for all advisory committee meetings
enough to provide timely notice. held at the White Oak campus, there are
Dated: February 24, 2015. Therefore, you should always check the instances where the Webcast
Barbara F. James, Agency’s Web site at http://www.fda. transmission is not successful; staff will
Designated Federal Officer, Chronic Fatigue gov/AdvisoryCommittees/default.htm work to re-establish the transmission as
Syndrome Advisory Committee. and scroll down to the appropriate soon as possible. The link for the
[FR Doc. 2015–05887 Filed 3–12–15; 8:45 am] advisory committee meeting link, or call Webcast is available at: https://
BILLING CODE 4150–42–P the advisory committee information line collaboration.fda.gov/gudpm052015/.
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![13396 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices
Further information regarding the posted to the docket at http:// proposed collection of information,
Webcast, including the Web address for www.regulations.gov. including the validity of the
the Webcast, will be made available at For press inquiries, please contact the methodology and assumptions used; (3)
least 2 days in advance of the meeting Office of Media Affairs at fdaoma@ Ways to enhance the quality, utility, and
at the following Web site: http://www. fda.hhs.gov or 301–796–4540. clarity of the information to be
fda.gov/AdvisoryCommittees/ Persons attending FDA’s advisory collected; and (4) Ways to minimize the
CommitteesMeetingMaterials/Medical committee meetings are advised that the burden of the collection of information
Devices/MedicalDevicesAdvisory Agency is not responsible for providing on those who are to respond, including
Committee/Gastroenterology-Urology access to electrical outlets. the use of appropriate automated,
DevicesPanel/default.htm. Select the FDA welcomes the attendance of the electronic, mechanical, or other
link for 2015 Meeting Materials. public at its advisory committee technological collection techniques or
Procedure: Interested persons may meetings and will make every effort to other forms of information technology.
present data, information, or views, accommodate persons with physical To Submit Comments and For Further
orally or in writing, on issues pending disabilities or special needs. If you Information: To obtain a copy of the
before the committee. Written require special accommodations due to data collection plans and instruments,
submissions may be made to the contact a disability, please contact AnnMarie submit comments in writing, or request
person on or before April 30, 2015. Oral Williams, at AnnMarie.Williams@ more information on the proposed
presentations from the public will be fda.hhs.gov or 301–796–5966 at least 7 project, contact: Deshiree Belis, 6705
scheduled between approximately 1 days in advance of the meeting. Rockledge Drive, Suite 6070, Bethesda,
p.m. and 2 p.m. on May 14 and between FDA is committed to the orderly MD 20892, or call non-toll-free number
approximately 9 a.m. and 10 a.m. on conduct of its advisory committee (301)-435–1032, or Email your request
May 15. Those individuals interested in meetings. Please visit our Web site at to: deshiree.belis@nih.gov. Formal
making formal oral presentations should http://www.fda.gov/Advisory requests for additional plans and
notify the contact person and submit a Committees/AboutAdvisoryCommittees/ instruments must be requested in
brief statement of the general nature of ucm111462.htm for procedures on writing.
public conduct during advisory Comments Due Date: Comments
the evidence or arguments they wish to
committee meetings. regarding this information collection are
present, the names and addresses of
Notice of this meeting is given under best assured of having their full effect if
proposed participants, and an
the Federal Advisory Committee Act (5 received within 60 days of the date of
indication of the approximate time
U.S.C. app. 2). this publication.
requested to make their presentation on Proposed Collection: Assessment of
or before April 15, 2015. Time allotted Dated: March 9, 2015.
NHLBI’s Global Health Initiative
for each presentation may be limited. If Leslie Kux,
Collaborating Centers of Excellence,
the number of registrants requesting to Associate Commissioner for Policy. 0925-New, National Heart, Lung, and
speak is greater than can be reasonably [FR Doc. 2015–05710 Filed 3–12–15; 8:45 am] Blood Institute (NHLBI), the National
accommodated during the scheduled BILLING CODE 4164–01–P Institutes of Health (NIH).
open public hearing session, FDA may Need and Use of Information
conduct a lottery to determine the Collection: This collection proposes to
speakers for the scheduled open public DEPARTMENT OF HEALTH AND conduct a one-time outcome evaluation
hearing session. The contact person will HUMAN SERVICES of the NHLBI Global Health Initiative
notify interested persons regarding their Centers of Excellence (GHI COE)
request to speak by April 20, 2015. National Institutes of Health Program to examine the extent to which
FDA is opening a docket for public the program achieved its intended
Proposed Collection; 60 Day Comment
comment on this document. The Docket objectives in developing sustainable
Request; Assessment of NHLBI’s
No. is FDA–2015–N–0722. The docket research and research training capacity,
Global Health Initiative Collaborating
will close on May 28, 2015. Interested and advancing information about the
Centers of Excellence (NHLBI)
persons are encouraged to use the prevention and treatment of chronic
docket to submit electronic or written SUMMARY: In compliance with the non-communicable chronic
comments regarding this meeting. requirement of Section 3506(c)(2)(A) of cardiovascular and pulmonary diseases
Comments received on or before April the Paperwork Reduction Act of 1995, (CVPD) in low- and middle-income
30, 2015, will be provided to the for opportunity for public comment on country (LMIC) populations. The
committee. Comments received after proposed data collection projects, the outcome evaluation will utilize a mixed-
that date will be taken into National Heart, Lung, and Blood methods approach to comprehend each
consideration by the Agency. Submit Institute (NHLBI), the National COE’s processes, short term outcomes,
electronic comments to http:// Institutes of Health (NIH), will publish and sustainability outcomes/efforts.
www.regulations.gov. Submit written periodic summaries of proposed Specifically, the evaluation will involve
comments to the Division of Dockets projects to the Office of Management triangulating quantitative data sources
Management, Food and Drug and Budget (OMB) for review and (e.g., archived systematic reporting
Administration, 5630 Fishers Lane, Rm. approval. data), and qualitative data sources (e.g.,
1061, Rockville, MD 20852. Submit a Written comments and/or suggestions archival data and key informant
single copy of electronic comments or from the public and affected agencies interview data). Data collected will be
mstockstill on DSK4VPTVN1PROD with NOTICES
two paper copies of any mailed are invited on one or more of the used to develop a Case Study report for
comments. Comments are to be following points: (1) Whether the each COE outlining their experience
identified with the docket number proposed collection of information is with implementing their program as
found in brackets in the heading of this necessary for the proper performance of well as a comprehensive cross-site
document. Received comments may be the function of the agency, including Lessons Learned Report describing
seen in the Divisions of Dockets whether the information will have knowledge and experiences from the
Management between 9 a.m. and 4 p.m., practical utility; (2) The accuracy of the overall program, including similarities
Monday through Friday, and will be agency’s estimate of the burden of the and differences across a variety of
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Document Created: 2015-12-18 11:41:32
Document Modified: 2015-12-18 11:41:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 80 FR 13395 |
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