[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