Document ID: FDA-2013-N-0001-0028
Agency: fda
Document Type: Notice
Title: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting
Posted Date: 2013-04-02T04:00Z

[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 http://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