Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 22280-22281 [2016-08737]

Download as PDF 22280 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Purpose of the Request for Information asabaliauskas on DSK3SPTVN1PROD with NOTICES and Cosmetic Act (21 U.S.C. 360eee and 360eee–1). Under section 582(j), FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. The projects established by FDA will take into consideration any pilot projects that were conducted prior to enactment of the DSCSA. ACTION: The request for information is intended to provide interested persons an opportunity to submit comments relating to FDA’s implementation of the DSCSA. We are particularly interested in comments regarding past or present pilot projects related to enhancing the safety and security of the pharmaceutical distribution supply chain. Stakeholders that may be interested in responding to this request for information include: Manufacturers, repackagers, wholesale distributors, dispensers, State and Federal authorities, solution providers, standards organizations, and other interested persons. FDA is particularly interested in learning about the practices, processes, and systems that supply chain stakeholders have used or considered using in such pilot projects. This includes, but is not limited to, information about the following: • Utilizing the product identifier for tracing of a product, which may include verification of the product identifier of a product, including the use of aggregation and inference; • Technical capabilities each sector of the supply chain to comply with systems and processes needed to utilize the product identifier to enhance the tracing of a product; or • System attributes that are necessary to implement the requirements established under the DSCSA. Interested persons are requested to provide any other relevant information that may assist with FDA’s development of a pilot project under the DSCSA. SUMMARY: Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08681 Filed 4–14–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 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. Notice, establishment of a public docket; request for comments. 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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 E:\FR\FM\15APN1.SGM 15APN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 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, Evella.Washington@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. 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 VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 22281 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 fdaoma@ fda.hhs.gov 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 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: 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1113] Data Integrity and Compliance With Current Good Manufacturing Practice; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Data Integrity and Compliance With CGMP.’’ The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. SUMMARY: E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22280-22281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08737]


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

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.

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

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, Evella.Washington@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.

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 
fdaoma@fda.hhs.gov 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 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: 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