Cardiovascular Metallic Implants: Corrosion, Surface Characterization, and Nickel Leaching; Public Workshop, 5813-5815 [2012-2583]
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5813
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FD&C Act section
502(u) ...................................................................................
1 There
[FR Doc. 2012–2555 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
10
Total annual
responses
100
Average
burden per
response
1,000
Total hours
.1
100
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
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: Oncologic Drugs
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 March 21, 2012, from 8 a.m. to
12:45 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
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on ‘‘Public Meetings at the FDA White
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Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
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Silver Spring, MD 20993–0002, (301)
796–9001, Fax: (301) 847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–(800)
741–8138 ((301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
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area. Please call the Information Line for
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Agenda: The committee will discuss
new drug application (NDA) 202497,
MARQIBO (vincristine sulfate
liposomes injection), application
submitted by Talon Therapeutics, Inc.
The proposed indication (use) for this
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will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
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default.htm. Scroll down to the
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Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
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submissions may be made to the contact
person on or before March 6, 2012. Oral
presentations from the public will be
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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
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requested to make their presentation on
or before February 27, 2012. 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
February 28, 2012.
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require special accommodations due to
a disability, please contact Caleb Briggs
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
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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: January 31, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–2460 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0057]
Cardiovascular Metallic Implants:
Corrosion, Surface Characterization,
and Nickel Leaching; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\06FEN1.SGM
06FEN1
5814
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Notices
Notice of public workshop;
request for comments.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Cardiovascular Metallic
Implants: Corrosion, Surface
Characterization, and Nickel Leaching.’’
The purpose of this public workshop is
to provide a forum for FDA,
cardiovascular device manufacturers,
test houses, and academia to discuss
corrosion, surface characterization, and
nickel leach testing, as well as to collect
comments and input regarding when
these assessments should be considered.
Dates and Time: The public workshop
will be held on March 8 and 9, 2012,
from 9 a.m. to 5:30 p.m. EST.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
rm. 1503 (the Great Room), Silver
Spring, MD 20993. For parking and
security information, please visit the
following Web site: https://www.fda.gov/
AboutFDA/WorkingatFDA/Buildingsand
Facilities/WhiteOakCampus
Information/ucm241740.htm. The
public workshop will also be available
to be viewed online via webcast.
Contact Persons:
Erica Takai, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, (301) 796–6353, FAX: (301)
796–9959, email:
erica.takai@fda.hhs.gov; or
Nicole Ibrahim, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, (301) 796–5171, email:
nicole.ibrahim@fda.hhs.gov.
Registration: To register for the public
workshop, please visit the following
Web site: https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm (or
go to https://www.fda.gov and select the
FDA Medical Devices News & Events—
Workshops & Conferences calendar and
select this public workshop from the
posted events list). Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone number. For those without
Internet access, please call the Contact
Person to register. Registration is
mandatory as space is limited and
onsite registration will not be available.
FDA may limit the number of
participants from each organization.
There is no registration fee for the
public workshop. Registration requests
should be received by 5 p.m. E.S.T. on
February 21, 2012.
VerDate Mar<15>2010
17:27 Feb 03, 2012
Jkt 226001
If you need special accommodations
due to a disability, please contact Susan
Monahan, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4321, Silver Spring,
MD 20993, (301) 796–5661 or email:
susan.monahan@fda.hhs.gov at least 7
days in advance of the workshop.
Streaming Webcast of the Public
Workshop: This workshop will also be
webcast. Persons interested in viewing
the webcast must register online by 5
p.m. E.S.T. on February 21, 2012. Early
registration is recommended because
webcast connections are limited.
Organizations are requested to register
all participants, but view using one
connection per location. Webcast
participants will be sent technical
system requirements after registration,
and will be sent connection access
information in a final confirmation
email by 5 p.m. E.S.T. on March 2, 2012.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register).
Workshop Participation: Participation
in the workshop will consist of both
lead participants and audience
members. Lead participants will include
representatives from various
organizations involved in or who
perform corrosion testing, surface
characterization, and/or nickel leach
testing and toxicological assessments of
nickel, such as industry, the medical
community, and test houses, and will be
driving the discussions. Lead
participants are expected to complete a
work assignment in advance of the
workshop in order to optimize the time
spent during the workshop. FDA will
compile the work assignment responses
prior to the workshop so that any
information provided from the
responding organization is deidentified.
If you wish to participate as a lead
participant, you must indicate this at
the time of registration. There will be a
tentative limit of one lead participant
per organization for industry and two
for test houses for each session, with a
total workshop participation limit of
two industry participants and three for
test houses, due to space limitations.
Audience members may be able to
participate in discussions, if time
permits.
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Additional Information: Background
information on the public workshop,
registration information, agenda,
information about lodging, food
services, and other relevant information
will be posted, as it becomes available,
on the Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm (or
go to https://www.fda.gov and select the
FDA Medical Devices News & Events—
Workshops and Conferences calendar
and select this public workshop from
the posted events list).
Comments: FDA is holding this public
workshop to obtain information on a
number of questions regarding
corrosion, surface characterization, and
nickel leaching. In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
written or electronic comments on all
aspects of the workshop topics. The
deadline for submitting comments
related to this public workshop is April
6, 2012.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic or written
comments. Submit electronic comments
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. In addition,
when responding to specific topics as
outlined in section II of this document,
please identify the topic you are
addressing. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday and will be
posted to the docket at https://
www.regulations.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Objectives
While the majority of cardiovascular
implants are made of metals and may be
susceptible to corrosion, it is unclear
whether the current corrosion testing
paradigm is predictive of in vivo
corrosion outcomes, or if there may be
more suitable assessments to predict
corrosion failure. In addition, there has
been an increase in the use of nitinol,
a nickel-titanium alloy, in
cardiovascular implants due to its
superelastic properties, which are ideal
for transcatheter-delivered therapies.
Corrosion of implant devices made of
nitinol and other nickel-containing
metal alloys (e.g. stainless steel, MP35N)
results in the release of nickel ions,
E:\FR\FM\06FEN1.SGM
06FEN1
Federal Register / Vol. 77, No. 24 / Monday, February 6, 2012 / Notices
which may lead to various modes of
toxicities. Furthermore, both nickel ion
release and corrosion characteristics are
dependent on surface finishing for
nitinol as well as for some other nickelcontaining alloys. Through the
collection of information from a preworkshop work assignment and
discussions with workshop participants,
FDA will be able to better determine
what assessments may be considered for
cardiovascular implants made of
commonly used metallic alloys, and this
information is expected to serve as the
foundation for a future guidance
document.
II. Topics for Discussion at the Public
Workshop
The objective of this workshop is to
provide a forum for discussion of the
following topics:
• The various methods that are used
for corrosion assessments, surface
characterization techniques, and nickel
leach testing used to evaluate the
suitability of metallic cardiovascular
implant devices;
• The limitations of each of these
tests to predict actual in vivo
performance;
• The need and utility for each test;
and
• The potential testing paradigms,
including when certain tests should be
considered, and how to establish
acceptance criteria for each test.
mstockstill on DSK4VPTVN1PROD with NOTICES
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the
transcripts will also be available on the
Internet at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm
(select this public workshop from the
posted events list), approximately 45
days after the public workshop.
Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–2583 Filed 2–3–12; 8:45 am]
BILLING CODE 4160–01–P
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Jkt 226001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Organ
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Organ
Transplantation (ACOT).
Date And Time: February 28, 2012, 10 am
to 4 p.m. Eastern Standard Time (EST).
Place: The meeting will be via audio
conference call and Adobe Connect Pro.
Status: The meeting will be open to the
public.
Purpose: Under the authority of 42 U.S.C.
Section 217a, Section 222 of the Public
Health Service Act, as amended, and 42 CFR
121.12 (2000), ACOT was established to
assist the Secretary in enhancing organ
donation, ensuring that the system of organ
transplantation is grounded in the best
available medical science, and assuring the
public that the system is as effective and
equitable as possible, thereby, increasing
public confidence in the integrity and
effectiveness of the transplantation system.
ACOT is composed of up to 25 members,
including the Chair. Members are serving as
Special Government Employees and have
diverse backgrounds in fields such as organ
donation, health care public policy,
transplantation medicine and surgery, critical
care medicine and other medical specialties
involved in the identification and referral of
donors, non-physician transplant
professions, nursing, epidemiology,
immunology, law and bioethics, behavioral
sciences, economics and statistics, as well as
representatives of transplant candidates,
transplant recipients, organ donors, and
family members.
Agenda: The Committee will hear reports
from the three ACOT Work Groups:
Declining Rates of Donation/Geographical
and Other Variations in Organ Distribution,
Alignment of CMS Regulatory Requirements
with OPTN and HRSA, and Brain Death
Determination. ACOT presentations will
include transplant tourism, and a report of
the Technical Expert Panel on death
determination in Uncontrolled Donation after
Circulatory Determination of Death (UDCDD).
Agenda items are subject to change as
priorities indicate.
After presentations and Committee
discussions, members of the public will have
an opportunity to provide comments.
Because of the Committee’s full agenda and
timeframe in which to cover the agenda
topics, public comment will be limited. All
public comments will be included in the
record of the ACOT meeting. Meeting
Summary notes will be posted on the
Department’s donation Web site at https://
www.organdonor.gov/legislation/
advisory.html#meetings. The draft meeting
agenda will be posted on https://www.teampsa.com/ACOT/February2012.
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5815
The public can join the meeting by:
1. [Audio Portion] Calling the Conference
Phone Number (888–790–3384) and
providing the Participant Code (6216514),
AND
2. [Visual Portion] Connecting to the ACOT
Adobe Connect Pro Meeting using the
following URL: https://
hrsa.connectsolutions.com/acot-22812/ (copy
and paste the link into your browser if it does
not work directly, and enter as a guest). The
conference call leader is Patricia A. Stroup.
Call (301) 443–0437 or send an email to
ptongele@hrsa.com if you are having trouble
connecting to the meeting site. Participants
should call and connect to the meeting no
later than 9:45 a.m. EST in order for logistics
to be set up. If you have never attended an
Adobe Pro Connect Meeting, please test your
connection using the following URL: https://
hrsa.connectsolutions.com/common/help/
en/support/meeting_test.htm. For a quick
overview, please access: https://www.adobe.
com/go/connectpro_overview.
Those planning on attending this
conference call should register by contacting
Brittany Carey, the Logistical Coordinator, at
bcarey@explorepsa.com (or by telephone at
(703) 889–9033) before the registration
deadline of February 24, 2012.
Public Comment: It is preferred that
persons interested in providing an oral
presentation submit a written request, along
with a copy of their presentation to: Passy
Tongele, Division of Transplantation,
Healthcare Systems Bureau (HSB), Health
Resources and Services Administration
(HRSA), Room 12C–06, 5600 Fishers Lane,
Rockville, Maryland 20857. Requests and
presentations also may be emailed to
ptongele@hrsa.gov. Requests should contain
the name, address, telephone number, email
address, and any business or professional
affiliation of the person desiring to make an
oral presentation. Groups having similar
interests are requested to combine their
comments and present them through a single
representative.
Persons may also request to speak at the
time of the public comment period. Public
participation and ability to comment may be
limited as time permits.
FOR FURTHER INFORMATION CONTACT:
Patricia Stroup, Executive Secretary,
ACOT, Healthcare Systems Bureau,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland
20857; telephone (301) 443–1127.
Dated: January 31, 2012.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2012–2646 Filed 2–3–12; 8:45 am]
BILLING CODE 4165–15–P
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]]>Agencies
[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]
[Notices]
[Pages 5813-5815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2583]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0057]
Cardiovascular Metallic Implants: Corrosion, Surface
Characterization, and Nickel Leaching; Public Workshop
AGENCY: Food and Drug Administration, HHS.
[[Page 5814]]
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Cardiovascular Metallic Implants: Corrosion,
Surface Characterization, and Nickel Leaching.'' The purpose of this
public workshop is to provide a forum for FDA, cardiovascular device
manufacturers, test houses, and academia to discuss corrosion, surface
characterization, and nickel leach testing, as well as to collect
comments and input regarding when these assessments should be
considered.
Dates and Time: The public workshop will be held on March 8 and 9,
2012, from 9 a.m. to 5:30 p.m. EST.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503 (the Great Room),
Silver Spring, MD 20993. For parking and security information, please
visit the following Web site: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The
public workshop will also be available to be viewed online via webcast.
Contact Persons:
Erica Takai, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
(301) 796-6353, FAX: (301) 796-9959, email: erica.takai@fda.hhs.gov; or
Nicole Ibrahim, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993,
(301) 796-5171, email: nicole.ibrahim@fda.hhs.gov.
Registration: To register for the public workshop, please visit the
following Web site: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to https://www.fda.gov and
select the FDA Medical Devices News & Events--Workshops & Conferences
calendar and select this public workshop from the posted events list).
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. For those without Internet access, please call the Contact
Person to register. Registration is mandatory as space is limited and
onsite registration will not be available. FDA may limit the number of
participants from each organization. There is no registration fee for
the public workshop. Registration requests should be received by 5 p.m.
E.S.T. on February 21, 2012.
If you need special accommodations due to a disability, please
contact Susan Monahan, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD 20993, (301) 796-
5661 or email: susan.monahan@fda.hhs.gov at least 7 days in advance of
the workshop.
Streaming Webcast of the Public Workshop: This workshop will also
be webcast. Persons interested in viewing the webcast must register
online by 5 p.m. E.S.T. on February 21, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but view using one connection
per location. Webcast participants will be sent technical system
requirements after registration, and will be sent connection access
information in a final confirmation email by 5 p.m. E.S.T. on March 2,
2012. If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. (FDA has verified
the Web site addresses in this document, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register).
Workshop Participation: Participation in the workshop will consist
of both lead participants and audience members. Lead participants will
include representatives from various organizations involved in or who
perform corrosion testing, surface characterization, and/or nickel
leach testing and toxicological assessments of nickel, such as
industry, the medical community, and test houses, and will be driving
the discussions. Lead participants are expected to complete a work
assignment in advance of the workshop in order to optimize the time
spent during the workshop. FDA will compile the work assignment
responses prior to the workshop so that any information provided from
the responding organization is de-identified.
If you wish to participate as a lead participant, you must indicate
this at the time of registration. There will be a tentative limit of
one lead participant per organization for industry and two for test
houses for each session, with a total workshop participation limit of
two industry participants and three for test houses, due to space
limitations. Audience members may be able to participate in
discussions, if time permits.
Additional Information: Background information on the public
workshop, registration information, agenda, information about lodging,
food services, and other relevant information will be posted, as it
becomes available, on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to
https://www.fda.gov and select the FDA Medical Devices News & Events--
Workshops and Conferences calendar and select this public workshop from
the posted events list).
Comments: FDA is holding this public workshop to obtain information
on a number of questions regarding corrosion, surface characterization,
and nickel leaching. In order to permit the widest possible opportunity
to obtain public comment, FDA is soliciting written or electronic
comments on all aspects of the workshop topics. The deadline for
submitting comments related to this public workshop is April 6, 2012.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments. Submit electronic
comments to https://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. In addition, when
responding to specific topics as outlined in section II of this
document, please identify the topic you are addressing. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday and will be posted to the docket
at https://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Objectives
While the majority of cardiovascular implants are made of metals
and may be susceptible to corrosion, it is unclear whether the current
corrosion testing paradigm is predictive of in vivo corrosion outcomes,
or if there may be more suitable assessments to predict corrosion
failure. In addition, there has been an increase in the use of nitinol,
a nickel-titanium alloy, in cardiovascular implants due to its
superelastic properties, which are ideal for transcatheter-delivered
therapies. Corrosion of implant devices made of nitinol and other
nickel-containing metal alloys (e.g. stainless steel, MP35N) results in
the release of nickel ions,
[[Page 5815]]
which may lead to various modes of toxicities. Furthermore, both nickel
ion release and corrosion characteristics are dependent on surface
finishing for nitinol as well as for some other nickel-containing
alloys. Through the collection of information from a pre-workshop work
assignment and discussions with workshop participants, FDA will be able
to better determine what assessments may be considered for
cardiovascular implants made of commonly used metallic alloys, and this
information is expected to serve as the foundation for a future
guidance document.
II. Topics for Discussion at the Public Workshop
The objective of this workshop is to provide a forum for discussion
of the following topics:
The various methods that are used for corrosion
assessments, surface characterization techniques, and nickel leach
testing used to evaluate the suitability of metallic cardiovascular
implant devices;
The limitations of each of these tests to predict actual
in vivo performance;
The need and utility for each test; and
The potential testing paradigms, including when certain
tests should be considered, and how to establish acceptance criteria
for each test.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the
posted events list), approximately 45 days after the public workshop.
Dated: February 1, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2583 Filed 2-3-12; 8:45 am]
BILLING CODE 4160-01-P
