Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule, 19717-19718 [2013-07568]
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Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
will be posted to the docket at https://
www.regulations.gov.
Transcripts: Transcripts will not be
provided.
SUPPLEMENTARY INFORMATION:
I. Background
Cardiovascular procedures are
performed in hundreds of thousands of
patients every year to treat all manner
of cardiovascular disease from coronary
artery disease to peripheral vascular
disease, intracardiac ablation to surgical
interventions, implant of stents to
implants of pacemakers, defibrillators,
and their associated leads. Information
obtained from clinical trials is often
limited due to small size, short
followup, and lack of generalizability.
Observational studies and registries
have become increasingly important
data sources for assessing the
performance of cardiovascular
therapeutic medical devices in the realworld setting. However, these registries
are often limited in scope and size to a
specific country, region, or health care
provider system.
Developing a comprehensive
understanding of the performance of
these devices requires not only an
indepth analysis across data sources to
link device use to clinical outcomes, but
also to incorporate data from
international experience with these
devices and procedures. FDA is holding
this workshop to discuss the
development of an international
consortium of cardiovascular registries
that would allow for broad-based
analysis and surveillance of medical
device exposure and related clinical
outcomes. This effort follows on the
successful model of the International
Consortium of Orthopedic Registries
(ICOR), which has developed a
framework for distributed analysis
across their member registries around
the world. The development of a similar
consortium of cardiovascular registries
will begin with a narrowed scope
incorporating transcatheter valve
therapy devices and procedures.
At the end of this workshop, FDA
intends that the participants and
stakeholders will develop a
comprehensive plan for the
development of an operational
international consortium of
cardiovascular registries. This plan will
identify specific issues that must be
addressed and provide a ‘‘roadmap’’ for
full implementation.
II. Topics
Topics to be discussed at this meeting
include:
• The role of registry consortia in
postmarket surveillance,
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• Goals of the International
Consortium of Cardiovascular
Registries,
• Lessons learned from the
development of the ICOR,
• Development of an international
consortium of transcatheter valve
registries as a pilot phase,
• Analysis of near- and long-term
outcomes reported through registries,
and
• Discussion of capabilities,
challenges, and limitations of existing
transcatheter valve registries.
Dated: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07579 Filed 4–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Clinical Chemistry and Clinical
Toxicology Devices Panel of the
Medical Devices Advisory Committee:
Notice of Change of Meeting Schedule
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Wednesday, February 27,
2013 (78 FR 13347). The meeting was
shortened to one day, as it was later
determined that in order to be more
financially prudent all three topics
could fit into one day.
FOR FURTHER INFORMATION CONTACT: Sara
J. Anderson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1611, Silver Spring,
MD 20993–0002,
Sara.Anderson@fda.hhs.gov, 301–796–
7047, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). Please call the Information Line
for up-to-date information on this
meeting.
SUMMARY:
In FR doc.
2013–04543, appearing on page 13347
in the Federal Register of Wednesday,
February 27, 2013, the following
correction is made:
1. On page 13347, in the first column,
under the section entitled ‘‘Date and
Time’’, the date is corrected to be April
25, 2013.
SUPPLEMENTARY INFORMATION:
PO 00000
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19717
2. On page 13347, in the second
column, the section entitled ‘‘Agenda’’
is corrected to read as follows:
Agenda: On April 25, 2013, the
committee will discuss and make
recommendations on the appropriate
regulatory classification for diagnostic
devices known as methotrexate enzyme
immunoassays. Methotrexate enzyme
immunoassays are considered preAmendment devices since they were in
commercial distribution prior to May
28, 1976, when the Medical Device
Amendments became effective.
Methotrexate enzyme immunoassays are
currently regulated under the heading of
‘‘Enzyme Immunoassay, Methotrexate,’’
Product Code LAO, as unclassified
under the 510(k) premarket notification
authority. Methotrexate enzyme
immunoassays are for the quantitative
determination of methotrexate. The
measurements obtained are used in
monitoring levels of methotrexate to
ensure appropriate drug therapy. FDA is
seeking panel input on the safety and
effectiveness of methotrexate enzyme
immunoassays.
The committee will also discuss and
make recommendations on the
appropriate regulatory classification for
diagnostic devices known as
phencyclidine (PCP) enzyme
immunoassays and PCP
radioimmunoassays. PCP enzyme
immunoassays and PCP
radioimmunoassays are considered preAmendment devices since they were in
commercial distribution prior to May
28, 1976 when the Medical Device
Amendments became effective. PCP
enzyme immunoassays are currently
regulated under the heading of ‘‘Enzyme
Immunoassay, Phencyclidine,’’ Product
Code LCM, and ‘‘Radioimmunoassay,
Phencyclidine,’’ Product Code LCL, as
unclassified under the 510(k) premarket
notification authority. FDA is seeking
panel input on the safety and
effectiveness of PCP enzyme
immunoassays and PCP
radioimmunoassays.
The committee will also discuss and
make recommendations on the
appropriate regulatory classification for
diagnostic devices known as isoniazid
test strips. Isoniazid test strips are
considered pre-Amendment devices
since they were in commercial
distribution prior to May 28, 1976 when
the Medical Device Amendments
became effective. Isoniazid test strips
are currently regulated under the
heading of ‘‘Strip, Test Isoniazid,’’
Product Code MIG, as unclassified
under the 510(k) premarket notification
authority. Isoniazid test strips are a
qualitative assay used for detecting
isonicotinic acid and its metabolites in
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02APN1
srobinson on DSK4SPTVN1PROD with NOTICES
19718
Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices
urine to determine compliance of
isoniazid (INH) medication. FDA is
seeking panel input on the safety and
effectiveness of isoniazid test strips.
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 https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
3. On page 13347, in the third
column, the section entitled
‘‘Procedure’’ is corrected to read as
follows:
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 16, 2013. On April 25, 2013, oral
presentations from the public regarding
Methotrexate Test Systems will be
scheduled between approximately 9:15
a.m. and 9:45 a.m.; regarding
phencyclidine (PCP) Test Systems
between approximately 1:55 p.m. and
2:25 p.m.; and regarding Isoniazid Test
Systems between approximately 4:15
p.m. and 4:45 p.m. 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 8,
2013. 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 9, 2013.
Dated: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–07568 Filed 4–1–13; 8:45 am]
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I. Background
SUMMARY:
A. Smoking and Tobacco Dependence
Tobacco use is the leading
preventable cause of death and disease
in the United States. According to an
estimate by the Centers for Disease
Control and Prevention, cigarette
smoking causes 443,000 deaths each
year in the United States, including
nearly 50,000 deaths per year from
involuntary exposure to tobacco smoke
(Ref. 1). Smoking is known to cause
multiple cancers, heart disease, stroke,
complications of pregnancy, chronic
obstructive pulmonary disease, and
many other diseases that, on average,
shorten smokers’ lifespans by 14 years
(Ref. 2).
Surveys show that approximately 70
percent of current smokers want to stop
smoking, and nearly half of all smokers
make a quit attempt each year (Ref. 3).
Unfortunately, dependence on
nicotine—the primary addictive
substance in tobacco—is a chronic
disease that often requires repeated
intervention and multiple quit attempts
to overcome. As a result, only a small
percentage of smokers successfully quit
each year (Ref. 3).
Submit labeling
supplements to the Center for Drug
Evaluation and Research, Food and
Drug Administration, Central Document
Room (CDR), 5901–B Ammendale Rd.,
Beltsville, MD 20705–1266. Copies of
the recommended revisions to product
labeling may be requested from the
Center for Drug Evaluation and
Research’s Division of Nonprescription
Clinical Evaluation, 10903 New
Hampshire Ave., Bldg. 22, Stop 5411,
Silver Spring, MD 20993, 301–796–
2080. Copies of published studies that
can be used to support labeling
supplements will be on display in the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, and can be seen by
interested persons between 9 a.m. and 4
p.m., Monday through Friday.
B. Over-the-Counter Nicotine
Replacement Therapies
Nicotine replacement therapy (NRT)
products are designed to help people
stop smoking by supplying controlled
amounts of nicotine to ease the
withdrawal symptoms associated with a
quit attempt. NRT products do not
contain all of the carcinogens and other
harmful constituents that are found in
cigarette smoke. There are currently
three types of NRT products approved
by FDA for over-the-counter (OTC) use
as smoking cessation aids: Nicotine
gum, transdermal nicotine patch, and
nicotine lozenge products.1 The
nicotine gum and patch products were
originally approved through the new
drug application (NDA) process between
1984 and 1992. Both the gum and the
patch were initially available by
prescription only; these products were
switched from prescription to OTC
status between 1996 and 2002. The
nicotine lozenge and mini-lozenge were
approved directly for OTC use in 2002
and 2009, respectively.
Currently, the FDA-approved labeling
for OTC NRT products instructs
consumers that they should stop
smoking when they begin using the
product and that they should not use
Food and Drug Administration
[Docket No. FDA–2013–N–0341]
Modifications To Labeling of Nicotine
Replacement Therapy Products for
Over-the-Counter Human Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that we have concluded that certain
statements set forth in the FDAapproved labels of over-the-counter
nicotine replacement therapy products,
related to concomitant use with other
nicotine-containing products and
duration of use, can be modified. In
light of currently available evidence,
these statements are no longer believed
to be necessary in their current form to
ensure the safe and effective use of overthe-counter nicotine replacement
therapy products for their approved
intended use as aids to smoking
cessation. We encourage the submission
of supplemental new drug applications
(labeling supplements) to modify these
statements as described in this notice.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris J. Bates, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4417,
Silver Spring, MD 20993, 301–796–
1040, FAX: 301–796–9721, email:
doris.bates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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1 A nicotine spray and a nicotine inhaler have
also been approved as smoking cessation aids.
However, these NRT products are available by
prescription only and are therefore outside the
scope of this notice.
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]]>Agencies
[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19717-19718]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07568]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee: Notice of Change of Meeting
Schedule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of Wednesday, February 27, 2013
(78 FR 13347). The meeting was shortened to one day, as it was later
determined that in order to be more financially prudent all three
topics could fit into one day.
FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002,
Sara.Anderson@fda.hhs.gov, 301-796-7047, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). Please call the Information Line for up-to-date information on
this meeting.
SUPPLEMENTARY INFORMATION: In FR doc. 2013-04543, appearing on page
13347 in the Federal Register of Wednesday, February 27, 2013, the
following correction is made:
1. On page 13347, in the first column, under the section entitled
``Date and Time'', the date is corrected to be April 25, 2013.
2. On page 13347, in the second column, the section entitled
``Agenda'' is corrected to read as follows:
Agenda: On April 25, 2013, the committee will discuss and make
recommendations on the appropriate regulatory classification for
diagnostic devices known as methotrexate enzyme immunoassays.
Methotrexate enzyme immunoassays are considered pre-Amendment devices
since they were in commercial distribution prior to May 28, 1976, when
the Medical Device Amendments became effective. Methotrexate enzyme
immunoassays are currently regulated under the heading of ``Enzyme
Immunoassay, Methotrexate,'' Product Code LAO, as unclassified under
the 510(k) premarket notification authority. Methotrexate enzyme
immunoassays are for the quantitative determination of methotrexate.
The measurements obtained are used in monitoring levels of methotrexate
to ensure appropriate drug therapy. FDA is seeking panel input on the
safety and effectiveness of methotrexate enzyme immunoassays.
The committee will also discuss and make recommendations on the
appropriate regulatory classification for diagnostic devices known as
phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP
enzyme immunoassays and PCP radioimmunoassays are considered pre-
Amendment devices since they were in commercial distribution prior to
May 28, 1976 when the Medical Device Amendments became effective. PCP
enzyme immunoassays are currently regulated under the heading of
``Enzyme Immunoassay, Phencyclidine,'' Product Code LCM, and
``Radioimmunoassay, Phencyclidine,'' Product Code LCL, as unclassified
under the 510(k) premarket notification authority. FDA is seeking panel
input on the safety and effectiveness of PCP enzyme immunoassays and
PCP radioimmunoassays.
The committee will also discuss and make recommendations on the
appropriate regulatory classification for diagnostic devices known as
isoniazid test strips. Isoniazid test strips are considered pre-
Amendment devices since they were in commercial distribution prior to
May 28, 1976 when the Medical Device Amendments became effective.
Isoniazid test strips are currently regulated under the heading of
``Strip, Test Isoniazid,'' Product Code MIG, as unclassified under the
510(k) premarket notification authority. Isoniazid test strips are a
qualitative assay used for detecting isonicotinic acid and its
metabolites in
[[Page 19718]]
urine to determine compliance of isoniazid (INH) medication. FDA is
seeking panel input on the safety and effectiveness of isoniazid test
strips.
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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
3. On page 13347, in the third column, the section entitled
``Procedure'' is corrected to read as follows:
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 16,
2013. On April 25, 2013, oral presentations from the public regarding
Methotrexate Test Systems will be scheduled between approximately 9:15
a.m. and 9:45 a.m.; regarding phencyclidine (PCP) Test Systems between
approximately 1:55 p.m. and 2:25 p.m.; and regarding Isoniazid Test
Systems between approximately 4:15 p.m. and 4:45 p.m. 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 8, 2013. 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 9, 2013.
Dated: March 27, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-07568 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P
