[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13347-13348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04543]
[[Page 13347]]
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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 Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Clinical Chemistry and Clinical Toxicology
Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 25 and 26, 2013,
from 8 a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel phone number is 301-948-8900.
Contact Person: 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,
[email protected], 301-796-7047, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: On April 25, 2013, during session I, 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.
On April 25, 2013, during session II, the committee will 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.
On April 26, 2013, the committee will 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 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 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
April 16, 2013. On April 25, 2013, oral presentations will be scheduled
between approximately 9:30 a.m. and 10 a.m. for session I and between 2
p.m. and 2:30 p.m. for session II. Oral presentations from the public
will be scheduled between 1 p.m. and 2 p.m. on April 26, 2013. 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.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Conference Management Staff, at [email protected] or 301-796-
5293, 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).
[[Page 13348]]
Dated: February 22, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04543 Filed 2-26-13; 8:45 am]
BILLING CODE 4160-01-P