[Federal Register Volume 62, Number 17 (Monday, January 27, 1997)]
[Notices]
[Pages 3901-3902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0456]


Home Access Health Corp.; Premarket Approval of the Home 
Access HIV-1 Test System

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 Home Access Health Corp. (HAHC), Hoffman 
Estates, IL, for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of the Home Access HIV-1 Test System. 
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 July 22, 1996, of the 
approval of the application.

DATES: Petitions for administrative review by February 26, 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), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-3524.

SUPPLEMENTARY INFORMATION: On June 1, 1995, HAHC, Hoffman Estates, IL 
60195-5200, submitted to CBER an application for premarket approval of 
the Home Access HIV-1 Test System. This product 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 Home Access HIV-1 Test 
System are: (1) The Vironostika HIV-1 Microelisa System 
manufactured by Organon Teknika Corp.; (2) the Genetic Systems LAV EIA 
HIV-1 enzyme immunoassay (EIA) manufactured by Genetic Systems; and (3) 
the Fluorognost HIV-1 immunoflourescence assay (IFA) 
manufactured by Waldheim Pharmazuetika. The HAHC testing service 
consists of: (1) The Home Access HIV-1 Home Collection Kit; 
(2) ClienttrakTM (Interactive Voice Response System, automated 
HIV/acquired immune deficiency syndrome (AIDS) educational 
announcement, and client database); (3) laboratory testing; and (4) 
counseling and referral services. Each collection kit contains: An 
instruction manual, an HIV/AIDS educational booklet in English and 
Spanish, a blood spot collection card precoded with a unique 11-digit 
Home Access code number, two safety lancets, an alcohol wipe, 
a sterile gauze pad, a bandage, a foil return pouch containing a 
desiccant, a safety lancet disposal container, a shipping container, 
and a preaddressed and prepaid return envelope. The test procedure 
begins when the client activates a unique 11-digit code number by 
calling a toll-free telephone number. Clients use the kit to obtain 
samples of their own blood which is placed on the collection card that 
is precoded with the code number. The collection card is mailed to HAHC 
using the provided mailer. Upon receipt, the sample is analyzed using 
enzyme linked immunosorbent assays licensed for the detection of HIV-1 
antibodies. Test results are available to the client from HAHC within 3 
business days after shipment of the sample to the laboratory for the 
Express Kit and within 7 days for the Standard Kit. The service is 
recommended for use by individuals 18 years of age or older.
    On June 22, 1994, CBER consulted 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

[[Page 3902]]

populations of HIV positive individuals or persons infected with other 
serious diseases, far outweigh 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 effectiveness of 
test kits in targeted populations. BPAC also recommended that pilot 
studies be performed to determine the effectiveness of such services in 
ensuring client anonymity and providing adequate counseling. CBER 
considered the BPAC recommendations during its review of the premarket 
approval application for the Home Access HIV-1 Test System. 
On July 22, 1996, CBER approved the application by a letter to the 
applicant from the Director, Office of Blood Research and Review, CBER.
    The July 22, 1996, application approval letter restated 
postapproval conditions agreed to by HAHC in three letters to FDA dated 
June 19, 1996, and July 12 and 22, 1996. These conditions incorporate 
the June 22, 1994, BPAC recommendations. The postapproval conditions 
include the following: (1) HAHC will perform postmarketing monitoring 
studies and, after consultation with CBER, submit a detailed study 
protocol within 30 days of the product's entry into interstate 
commerce; (2) HAHC will qualify all test kits and perform acceptance 
testing on all lots to be used with the Home Access HIV-1 
Test System, including the Vironostika HIV-1 Microelisa 
System manufactured by Organon Teknika Corp. and Fluorognost 
HIV-1 IFA manufactured by Waldheim Pharmazuetika; (3) HAHC 
will not use Genetic Systems Corp. LAV EIA until the reagents for that 
assay have passed lot acceptance protocols; (4) HAHC will not 
commercialize the ``Standard Kit'' until transport claims for the U.S. 
Mail have been verified to have an acceptable rate of loss; (5) HAHC 
will change the accuracy claim of the Home Access HIV-1 Test 
System from ``greater than 99.99% accurate'' to ``greater than 99.9% 
accurate;'' and (6) the package insert will be revised as described in 
a July 12, 1996, letter.
    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 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 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 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 February 26, 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 Devices and Radiological 
Health (21 CFR 5.53).

    Dated: January 7, 1997.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-1852 Filed 1-24-97; 8:45 am]
BILLING CODE 4160-01-F