[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