[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]
BILLING CODE 4160-01-F