[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
