81_FR_22353 81 FR 22280 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

81 FR 22280 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 73 (April 15, 2016)

Page Range22280-22281
FR Document2016-08737

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory 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. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 81 Issue 73 (Friday, April 15, 2016) 
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22280-22281]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1126]


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Circulatory System Devices 
Panel of the Medical Devices Advisory 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. FDA 
is establishing a docket for public comment on this document.

DATES: The meeting will be held on June 2 and 3, 2016, from 8 a.m. to 6 
p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 
Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301-
977-8900. 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. You may 
submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-1126 for ``Circulatory System Devices Panel of the Medical 
Devices Advisory Committee; Notice of Meeting; Establishment of a 
Public Docket; Request for Comments.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in

[[Page 22281]]

accordance with 21 CFR 10.20 and other applicable disclosure law. For 
more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301-
796-5290, [email protected], 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: On June 2 and 3, 2016, the committee will discuss recent 
reports and epidemiologic investigations of nontuberculous mycobacteria 
(NTM) infections associated with the use of heater-cooler devices 
during cardiac surgical procedures. FDA is convening this committee to 
seek expert scientific and clinical opinion related to contamination of 
heater-cooler devices, associated patient infections, and mitigation 
strategies based on available scientific information. The committee 
will make recommendations on: (1) The effectiveness of cleaning and 
disinfection methods for heater-cooler devices; (2) the amount and type 
of premarket data and information needed to demonstrate validation of 
cleaning and disinfection of heater-cooler devices in support of 
labeling claims and technical instructions; (3) appropriate risk 
mitigations to be implemented by manufacturers of heater-cooler devices 
and/or hospital facilities to ensure patient safety during surgical 
procedures where these devices are used; and (4) appropriate guidelines 
and/or criteria based on a risk stratification schema for notifying 
patients who may have already been exposed to NTM during prior cardiac 
surgeries. Recommendations on these issues will assist FDA in 
minimizing patient exposure to infections that may result from 
contaminated heater-cooler devices.
    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.
    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 May 
19, 2016. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on June 2, 2016, and between 
approximately 9 a.m. and 10 a.m. on June 3, 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 May 11, 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 May 12, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is establishing a docket for public comment on this document. 
The docket number is FDA-2016-N-1126. The docket will close on June 16, 
2016. Comments received on or before May 19, 2016, will be provided to 
the committee. Comments received after that date will be taken into 
consideration by the Agency.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    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 [email protected], 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: April 12, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-08737 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P

22280 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices and Cosmetic Act (21 U.S.C. 360eee and DEPARTMENT OF HEALTH AND comments, that information will be 360eee–1). Under section 582(j), FDA is HUMAN SERVICES posted on http://www.regulations.gov. required to establish one or more pilot • If you want to submit a comment projects, in coordination with Food and Drug Administration with confidential information that you authorized manufacturers, repackagers, do not wish to be made available to the [Docket No. FDA–2016–N–1126] public, submit the comment as a wholesale distributors, and dispensers, to explore and evaluate methods to written/paper submission and in the Circulatory System Devices Panel of enhance the safety and security of the manner detailed (see ‘‘Written/Paper the Medical Devices Advisory Submissions’’ and ‘‘Instructions’’). pharmaceutical distribution supply Committee; Notice of Meeting; chain. The projects established by FDA Establishment of a Public Docket; Written/Paper Submissions will take into consideration any pilot Request for Comments Submit written/paper submissions as projects that were conducted prior to follows: AGENCY: Food and Drug Administration, enactment of the DSCSA. HHS. • Mail/Hand delivery/Courier (for written/paper submissions): Division of II. Purpose of the Request for ACTION: Notice, establishment of a Dockets Management (HFA–305), Food Information public docket; request for comments. and Drug Administration, 5630 Fishers The request for information is SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. intended to provide interested persons • For written/paper comments Administration (FDA) announces a submitted to the Division of Dockets an opportunity to submit comments forthcoming public advisory committee Management, FDA will post your relating to FDA’s implementation of the meeting of the Circulatory System comment, as well as any attachments, DSCSA. We are particularly interested Devices Panel of the Medical Devices except for information submitted, in comments regarding past or present Advisory Committee. The general marked and identified, as confidential, pilot projects related to enhancing the function of the committee is to provide if submitted as detailed in safety and security of the advice and recommendations to the ‘‘Instructions.’’ pharmaceutical distribution supply Agency on FDA’s regulatory issues. The Instructions: All submissions received chain. Stakeholders that may be meeting will be open to the public. FDA must include the Docket No. FDA– interested in responding to this request is establishing a docket for public 2016–N–1126 for ‘‘Circulatory System for information include: Manufacturers, comment on this document. Devices Panel of the Medical Devices repackagers, wholesale distributors, DATES: The meeting will be held on June Advisory Committee; Notice of Meeting; dispensers, State and Federal 2 and 3, 2016, from 8 a.m. to 6 p.m. Establishment of a Public Docket; authorities, solution providers, ADDRESSES: Hilton Washington DC Request for Comments.’’ Received standards organizations, and other North/Gaithersburg, Grand Ballroom, comments will be placed in the docket interested persons. FDA is particularly 620 Perry Pkwy., Gaithersburg, MD and, except for those submitted as interested in learning about the 20877. The hotel telephone number is ‘‘Confidential Submissions,’’ publicly practices, processes, and systems that 301–977–8900. Answers to commonly viewable at http://www.regulations.gov supply chain stakeholders have used or asked questions including information or at the Division of Dockets considered using in such pilot projects. regarding special accommodations due Management between 9 a.m. and 4 p.m., This includes, but is not limited to, to a disability, visitor parking, and Monday through Friday. transportation may be accessed at: • Confidential Submissions—To information about the following: http://www.fda.gov/ submit a comment with confidential • Utilizing the product identifier for AdvisoryCommittees/ information that you do not wish to be tracing of a product, which may include AboutAdvisoryCommittees/ made publicly available, submit your verification of the product identifier of ucm408555.htm. You may submit comments only as a written/paper a product, including the use of comments as follows: submission. You should submit two aggregation and inference; copies total. One copy will include the Electronic Submissions information you claim to be confidential • Technical capabilities each sector of the supply chain to comply with Submit electronic comments in the with a heading or cover note that states systems and processes needed to utilize following way: ‘‘THIS DOCUMENT CONTAINS the product identifier to enhance the • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The www.regulations.gov. Follow the Agency will review this copy, including tracing of a product; or instructions for submitting comments. the claimed confidential information, in • System attributes that are necessary Comments submitted electronically, its consideration of comments. The to implement the requirements including attachments, to http:// second copy, which will have the established under the DSCSA. www.regulations.gov will be posted to claimed confidential information Interested persons are requested to the docket unchanged. Because your redacted/blacked out, will be available provide any other relevant information comment will be made public, you are for public viewing and posted on http:// that may assist with FDA’s development solely responsible for ensuring that your www.regulations.gov. Submit both of a pilot project under the DSCSA. comment does not include any copies to the Division of Dockets confidential information that you or a Management. If you do not wish your asabaliauskas on DSK3SPTVN1PROD with NOTICES Dated: April 11, 2016. third party may not wish to be posted, name and contact information to be Leslie Kux, such as medical information, your or made publicly available, you can Associate Commissioner for Policy. anyone else’s Social Security number, or provide this information on the cover [FR Doc. 2016–08681 Filed 4–14–16; 8:45 am] confidential business information, such sheet and not in the body of your BILLING CODE 4164–01–P as a manufacturing process. Please note comments and you must identify this that if you include your name, contact information as ‘‘confidential.’’ Any information, or other information that information marked as ‘‘confidential’’ identifies you in the body of your will not be disclosed except in VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1

Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22281 accordance with 21 CFR 10.20 and other and/or hospital facilities to ensure 19, 2016, will be provided to the applicable disclosure law. For more patient safety during surgical committee. Comments received after information about FDA’s posting of procedures where these devices are that date will be taken into comments to public dockets, see 80 FR used; and (4) appropriate guidelines consideration by the Agency. 56469, September 18, 2015, or access and/or criteria based on a risk For press inquiries, please contact the the information at: http://www.fda.gov/ stratification schema for notifying Office of Media Affairs at fdaoma@ regulatoryinformation/dockets/ patients who may have already been fda.hhs.gov or 301–796–4540. default.htm. exposed to NTM during prior cardiac FDA welcomes the attendance of the Docket: For access to the docket to surgeries. Recommendations on these public at its advisory committee read background documents or the issues will assist FDA in minimizing meetings and will make every effort to electronic and written/paper comments patient exposure to infections that may accommodate persons with disabilities. received, go to http:// result from contaminated heater-cooler If you require accommodations due to a www.regulations.gov and insert the devices. disability, please contact AnnMarie docket number, found in brackets in the FDA intends to make background Williams, at AnnMarie.Williams@ heading of this document, into the material available to the public no later fda.hhs.gov, or 301–796–5966, at least 7 ‘‘Search’’ box and follow the prompts than 2 business days before the meeting. days in advance of the meeting. and/or go to the Division of Dockets If FDA is unable to post the background FDA is committed to the orderly Management, 5630 Fishers Lane, Rm. material on its Web site prior to the conduct of its advisory committee 1061, Rockville, MD 20852. meeting, the background material will meetings. Please visit our Web site at FOR FURTHER INFORMATION CONTACT: be made publicly available at the http://www.fda.gov/ Evella Washington, Center for Devices location of the advisory committee AdvisoryCommittees/ and Radiological Health, Food and Drug meeting, and the background material AboutAdvisoryCommittees/ Administration, 10903 New Hampshire will be posted on FDA’s Web site after ucm111462.htm for procedures on Ave., Bldg. 66, Rm. 1535, Silver Spring, the meeting. Background material is public conduct during advisory MD 20993–0002, 301–796–5290, available at http://www.fda.gov/ committee meetings. Evella.Washington@fda.hhs.gov, or FDA AdvisoryCommittees/Calendar/ Notice of this meeting is given under Advisory Committee Information Line, default.htm. Scroll down to the the Federal Advisory Committee Act (5 1–800–741–8138 (301–443–0572 in the appropriate advisory committee meeting U.S.C. app. 2). Washington, DC area). A notice in the link. Procedure: Interested persons may Dated: April 12, 2016. Federal Register about last minute Jill Hartzler Warner, modifications that impact a previously present data, information, or views, announced advisory committee meeting orally or in writing, on issues pending Associate Commissioner for Special Medical before the committee. Written Programs. cannot always be published quickly enough to provide timely notice. submissions may be made to the contact [FR Doc. 2016–08737 Filed 4–14–16; 8:45 am] Therefore, you should always check the person on or before May 19, 2016. Oral BILLING CODE 4164–01–P presentations from the public will be Agency’s Web site at http:// scheduled between approximately 1 www.fda.gov/AdvisoryCommittees/ p.m. and 2 p.m. on June 2, 2016, and DEPARTMENT OF HEALTH AND default.htm and scroll down to the between approximately 9 a.m. and 10 HUMAN SERVICES appropriate advisory committee meeting a.m. on June 3, 2016. Those individuals link, or call the advisory committee Food and Drug Administration interested in making formal oral information line to learn about possible presentations should notify the contact modifications before coming to the [Docket No. FDA–2016–D–1113] person and submit a brief statement of meeting. the general nature of the evidence or Data Integrity and Compliance With SUPPLEMENTARY INFORMATION: arguments they wish to present, the Current Good Manufacturing Practice; Agenda: On June 2 and 3, 2016, the names and addresses of proposed Draft Guidance for Industry; committee will discuss recent reports participants, and an indication of the Availability and epidemiologic investigations of approximate time requested to make nontuberculous mycobacteria (NTM) their presentation on or before May 11, AGENCY: Food and Drug Administration, infections associated with the use of 2016. Time allotted for each HHS. heater-cooler devices during cardiac presentation may be limited. If the ACTION: Notice of availability. surgical procedures. FDA is convening number of registrants requesting to this committee to seek expert scientific speak is greater than can be reasonably SUMMARY: The Food and Drug and clinical opinion related to accommodated during the scheduled Administration (FDA or Agency) is contamination of heater-cooler devices, open public hearing session, FDA may announcing the availability of a draft associated patient infections, and conduct a lottery to determine the guidance for industry entitled ‘‘Data mitigation strategies based on available speakers for the scheduled open public Integrity and Compliance With CGMP.’’ scientific information. The committee hearing session. The contact person will The purpose of the draft guidance is to will make recommendations on: (1) The notify interested persons regarding their clarify the role of data integrity in effectiveness of cleaning and request to speak by May 12, 2016. current good manufacturing practice disinfection methods for heater-cooler Persons attending FDA’s advisory (CGMP) for drugs. The draft guidance is asabaliauskas on DSK3SPTVN1PROD with NOTICES devices; (2) the amount and type of committee meetings are advised that the in response to an increase in CGMP premarket data and information needed Agency is not responsible for providing violations involving data integrity to demonstrate validation of cleaning access to electrical outlets. observed in recent CGMP inspections. and disinfection of heater-cooler devices FDA is establishing a docket for When finalized, the draft guidance is in support of labeling claims and public comment on this document. The intended to provide the Agency’s technical instructions; (3) appropriate docket number is FDA–2016–N–1126. current thinking on the creation and risk mitigations to be implemented by The docket will close on June 16, 2016. handling of data in accordance with manufacturers of heater-cooler devices Comments received on or before May CGMP requirements. VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1


Document Created: 2016-04-15 00:55:28
Document Modified: 2016-04-15 00:55:28
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, establishment of a public docket; request for comments.
DatesThe meeting will be held on June 2 and 3, 2016, from 8 a.m. to 6 p.m.
ContactEvella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301- 796-5290, [email protected], 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.
FR Citation81 FR 22280 
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