[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9353]


[[Page Unknown]]

[Federal Register: April 19, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0067]

 

MBf USA, Inc.; Premarket Approval of AWARE Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by MBf USA, Inc., Boca Raton, FL, for 
premarket approval, under section 515 of the Federal Food, Drug, and 
Cosmetic Act (the act), of the AWARE Test System. The Clinical 
Chemistry and Toxicology Devices Panel recommendation of approval, with 
conditions, was made at a November 4, 1991, panel meeting. Approval was 
originally sought for over-the-counter (OTC) use by the applicant. 
However, FDA has decided that this panel meeting did not consider 
various issues, and so the panel will resume deliberating OTC use at a 
second meeting. As a result of the need for a second panel meeting, the 
applicant revised the indications for use to reflect a more limited 
use. After reviewing the recommendation of the Clinical Chemistry and 
Toxicology Devices Panel, FDA's Center for Devices and Radiological 
Health (CDRH) notified the applicant, by letter of January 18, 1994, of 
the approval of the application.

DATES: Petitions for administrative review by May 19, 1994.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kaiser J. Aziz, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION: On December 13, 1990, American Drug Screens, 
Inc., Oklahoma City, OK 73108, submitted to CDRH an application for 
premarket approval of the AWARE Test System. The device system has 
since been sold to MBf USA, Inc., 5100 Town Center Circle, suite 440, 
Boca Raton, FL 33486. This device is indicated for use as a specimen 
collection container and mailing kit and for drug analysis to determine 
if significant levels of marijuana, cocaine, amphetamines, 
phencyclidine (PCP), and/or codeine or morphine are present in a urine 
sample. It is restricted to use by physicians or professionals who 
counsel or treat individuals in connection with drug abuse. This system 
is not indicated for employee drug abuse testing, and it is not 
available with chain of custody. It is for in vitro diagnostic use 
only, and it is not for sale or distribution to pharmacies.
    On November 4, 1991, the Clinical Chemistry and Toxicology Devices 
Panel of the Medical Devices Advisory Committee, an FDA advisory 
committee, reviewed and recommended approval, with conditions, of the 
application. On January 18, 1994, CDRH approved the application by a 
letter to the applicant from the Acting Director of the Office of 
Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act (21 
U.S.C. 360e(g)), for administrative review of CDRH's decision to 
approve this application. A petitioner may request either a formal 
hearing under part 12 (21 CFR part 12) of FDA's administrative 
practices and procedures regulations or a review of the application and 
CDRH's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner shall identify the form 
of review requested (hearing or independent advisory committee) and 
shall submit with the petition supporting data and information showing 
that there is a genuine and substantial issue of material fact for 
resolution through administrative review. After reviewing the petition, 
FDA will decide whether to grant or deny the petition and will publish 
a notice of its decision in the Federal Register. If FDA grants the 
petition, the notice will state the issue to be reviewed, the form of 
review to be used, the persons who may participate in the review, the 
time and place where the review will occur, and other details.
    Petitioners may, at any time on or before May 19, 1994, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: April 5, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-9353 Filed 4-18-94; 8:45 am]
BILLING CODE 4160-01-F