[Federal Register Volume 61, Number 243 (Tuesday, December 17, 1996)]
[Notices]
[Pages 66283-66284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31935]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0350]
Roche Molecular Systems, Inc.; Premarket Approval of Roche
Amplicor HIV-1 Monitor Test
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Roche Molecular Systems, Inc.,
Somerville, NJ, for premarket approval, under the Federal Food, Drug,
and Cosmetic Act (the act), of the Roche Amplicor HIV-1 Monitor Test.
After reviewing the recommendation of the Blood Products Advisory
Committee (BPAC), FDA's Center for Biologics Evaluation and Research
(CBER) notified the applicant, by letter of June 3, 1996, of the
approval of the application.
DATES: Petitions for administrative review by January 16, 1997.
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,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Sukza Hwangbo, Center for Biologics
Evaluation and Research (HFM-380), 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-3524.
SUPPLEMENTARY INFORMATION: On November 3, 1995, Roche Molecular
Systems, Inc., Summerville, NJ 08876-3771, submitted to CBER an
application for premarket approval of the Roche Amplicor HIV-1 Monitor
Test. The device is intended to quantitate human immunodeficiency virus
Type 1 (HIV-1) ribonucleic acid (RNA) in human plasma and is to be used
in conjunction with clinical presentation and other laboratory markers
as an indicator of HIV-1 disease prognosis. The Amplicor HIV-1 Monitor
Test is based on the following processes: (1) Reverse transcriptase
(RT) of target HIV-1 RNA to generate complimentary deoxyribonucleic
acid (cDNA); (2) polymerase chain reaction (PCR) amplification of
target cDNA; (3) hybridization of PCR amplified cDNA to specific
oligonucleotide probes; and (4) detection of the probe-cDNA complex by
colorimetric means. The device is not intended to be used as a HIV-1
screening test, or as a diagnostic test to confirm the presence of HIV
infection.
On March 21, 1996, the premarket approval application (PMA) was
referred to BPAC, an FDA advisory committee, for its recommendation
regarding the use of the Amplicor HIV-1 Monitor Test to assist in
disease prognosis, monitoring therapy, and patient management. From
data presented by FDA, BPAC determined the test to be capable of
precise and accurate measurement of HIV-1 RNA in samples of human
plasma. BPAC recommended that the Amplicor HIV-1 Monitor Test was
acceptable for use in the prognosis of HIV disease in specific
populations, e.g., patients with CD4 positive cells of a predefined
level. BPAC stated that they viewed therapy monitoring and patient
management as being closely related, nonseparable issues and that
sufficient clinical studies had not been performed to demonstrate the
utility of the Amplicor HIV-1 Monitor Test for such uses. BPAC
recommended that further postmarket surveillance studies could be
conducted to determine whether the Amplicor HIV-1 Monitor Test could be
validated for uses other than prognosis, i.e., therapy monitoring and
patient management. CBER considered the BPAC recommendations and
opinions when conducting its review of the PMA for the Amplicor HIV-1
Monitor Test. On June 3, 1996, CBER approved the application by a
letter to the applicant from the Director, Office of Blood Research and
Review, CBER.
The June 3, 1996, application approval letter restated postapproval
conditions previously agreed to by Roche Molecular Systems, Inc., in a
May 31, 1996, letter to FDA, whereby Roche Molecular Systems, Inc.,
will: (1) Perform postapproval studies to correlate measurements made
with the Amplicor HIV-1 Monitor Test with
[[Page 66284]]
clinical endpoints; (2) train laboratory personnel in the use of the
Amplicor HIV-1 Monitor Test at Roche Diagnostics corporate headquarters
training facility and at customers' facilities to include discussions
of the basic principles of PCR nucleic acid amplification, the design
and maintenance of a nucleic acid amplification laboratory, management
of workflow, equipment maintenance, and trouble shooting techniques;
(3) provide the agency with lot release test results for the first
three commercial lots of the Amplicor HIV-1 Monitor Test, submit lot
release data for every third lot for a period of 12 months
postapproval, and comply with agency determinations regarding the need
for submissions of lot release data beyond the 1-year postapproval
period; and (4) develop and provide physician and patient educational
materials to include information on HIV infection, acquired immune
deficiency syndrome (AIDS), anti-viral treatment modalities, viral load
testing, the Amplicor HIV-1 Monitor Test, and a statement that the
clinical significance of HIV-1 RNA measurements has not been fully
established and that studies are in progress to determine the role of
HIV RNA measurements.
A summary of the safety and effectiveness data on which CBER 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, for
administrative review of CBER'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 CBER'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 January 16, 1997, 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 Director, Center for Biologics Evaluation and
Research (21 CFR 5.53).
Dated: November 26, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-31935 Filed 12-16-96; 8:45 am]
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