[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19717-19718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07568]
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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 Change of Meeting
Schedule
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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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,
[email protected], 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]
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