[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Notices]
[Pages 57446-57447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28580]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0330]
Direct Access Diagnostics; Premarket Approval of
Confide HIV Testing Service Using Dried Blood Spots
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 Direct Access Diagnostics, Bridgewater,
NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of the Confide HIV Testing Service Using Dried
Blood Spots (Confide HIV Testing Service). After reviewing
the recommendation of the Blood Products Advisory Committee, FDA's
Center for Biologics Evaluation and Research (CBER) notified the
applicant, by letter of May 14, 1996, of the approval of the
application.
DATES: Petitions for administrative review by December 6, 1996.
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 December 30, 1987, Direct Access
Diagnostics, Bridgewater, NJ 08807, submitted to CBER an application
for premarket approval of the Confide HIV Testing Service
Using Dried Blood Spots. The service is intended for self-use by
individuals who wish to obtain anonymous human immunodeficiency virus
Type 1 (HIV-1) testing and counseling. The HIV-1 assay kits approved
for use in the Confide HIV Testing Service are: Vironostika
HIV-1 Microelisa System manufactured by Organon Teknika Corp., Genetic
Systems LAV EIA manufactured by Genetic Systems Corp., Fluorognost HIV-
1 IFA manufactured by Waldheim Pharmazuetika, and HIV-1 Western Blot
Kit manufactured by Cambridge Biotech Corp. The Confide HIV
Testing Service is a single use test kit consisting of aseptic wipes,
two finger-stick lancets, a test card precoded with a personal
identification number (PIN), an identification (ID) card which also
contains the PIN, a postage-paid, pre-addressed mailer and instructions
for use. Accompanying the instructions is a brochure explaining
important facts about HIV-1 infection and transmission, HIV-1 testing
and acquired immune deficiency syndrome (AIDS). An individual will use
the test kit to obtain a sample of their own blood. The blood sample is
placed on the designated area of the test card, identified only by a
unique PIN, and mailed to Direct Access Diagnostics using the provided
mailer. Upon receipt, the test is analyzed by Direct Access Diagnostics
using enzyme-linked immunosorbent assays (ELISA) licensed for the
detection of HIV-1 antibodies. Results are released to the individual
in possession of the ID card and PIN. The device is intended for use
with individuals 18 years of age or older.
On June 22, 1994, CBER consulted the Blood Products Advisory
Committee (BPAC), an FDA advisory committee, for their comments and
recommendations regarding issues FDA should address when reviewing home
collection testing kits for the detection of HIV and other serious or
life-threatening medical conditions. BPAC commented that the benefits
of an alternative means of accessing previously unreachable populations
of HIV positive individuals or persons infected with other serious
diseases, far outweighed any risk to the individual's health posed by
the test kit protocol or to the public's health by home testing. BPAC
recommended that pilot studies be conducted to assess demographically,
qualitatively, and quantitatively the test's effectiveness in targeted
populations. BPAC also recommended that pilot studies be performed to
determine the test's effectiveness in ensuring client anonymity and
providing adequate counseling. CBER considered the BPAC recommendations
during its review of the premarket approval application for the
Confide HIV Testing Service. On May 14, 1996, CBER approved
the application by a letter to the applicant from the Director, Center
for Biologics Evaluation and Review.
The May 14, 1996, application approval letter restated post-
approval conditions agreed to by Direct Access Diagnostics in a May 8,
1996, letter to FDA. These conditions incorporate the June 22, 1994,
BPAC recommendations. Under the terms of the post-approval conditions
Direct Access Diagnostics will: (1) Be fully responsible for product
qualifications and acceptance testing of all tests utilized in the
Confide HIV Testing Service and report test results to the
agency every 6 months; (2) collect demographic and risk behavior
surveillance data, at both the State and national level, for a period
of 3 years
[[Page 57447]]
post-approval, from all clients with positive or inconclusive results
and from a random sampling of clients who test negative, and to
expedite post-approval the collection of demographic information from
all clients who test negative; (3) compare, for 3 years post-approval,
demographic data of Confide HIV Testing Service clients with
data obtained from persons using other testing services; and (4)
conduct a first year post-approval study to determine the proportion of
test cards submitted with adequate samples.
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 December 6, 1996, 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: October 18, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-28580 Filed 11-5-96; 8:45 am]
BILLING CODE 4160-01-F
