[Federal Register Volume 64, Number 243 (Monday, December 20, 1999)]
[Notices]
[Pages 71147-71148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0483]


Guidance for Industry: In the Manufacture and Clinical Evaluation 
of In Vitro Tests to Detect Nucleic Acid Sequences of Human 
Immunodeficiency Viruses Types 1 and 2; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Industry: 
In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect 
Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 
2.'' The guidance document addresses general and specific concerns for 
gene based detection techniques for human immunodeficiency virus (HIV). 
The document provides guidance on manufacturing and clinical trial 
design issues pertaining to the validation of tests based on nucleic 
acid detection either in the presence or absence of an amplification 
step.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry: In the Manufacture and 
Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences 
of Human Immunodeficiency Viruses Types 1 and 2'' to the Office of 
Communication, Training, and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. The guidance document may also be obtained by mail by calling 
the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or 
by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-
827-3844. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
     Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

 I. Background

     FDA is announcing the availability of a guidance document entitled 
``Guidance for Industry: In the Manufacture and Clinical Evaluation of 
In Vitro Tests to Detect Nucleic Acid Sequences of Human 
Immunodeficiency Viruses Types 1 and 2.'' The guidance document 
announced in this notice finalizes the draft guidance entitled 
``Guidance for Industry in the Manufacture and Clinical Evaluation of 
In Vitro Tests to Detect Nucleic Acid Sequences of Human 
Immunodeficiency Virus Type 1'' published in the Federal Register of 
July 10, 1998 (63 FR 37402). The guidance document clarifies the 
following issues as a result of public comments submitted on the draft 
guidance document: (1) The definition of limit of detection and limit 
of quantitation for a nucleic acid test and laboratory studies 
recommended for validation of these limits; (2) the analytical 
sensitivity study recommendations, including the FDA standard for 
sensitivity of the pool test in the case of nucleic acid testing, for 
testing pooled plasma; (3) the numbers of sites, specimens, and design 
of clinical specificity and sensitivity studies recommended for pooled 
plasma tests; and (4) the clinical studies to validate a claim for 
viral load tests used in patient management, i.e., prognosis and 
therapy.
     The guidance document outlines some of the major regulatory and 
scientific issues concerning gene based tests for HIV-1 and HIV-2. 
These considerations also apply to tests for other transfusion 
transmitted viruses including hepatitis C virus, hepatitis B virus, and 
human T-cell Lymphotropic viruses types I and II.
     The guidance document represents the agency's current thinking 
with regard to the manufacture and clinical evaluation of in vitro 
testing to detect specific nucleic acid sequences of HIV types 1 and 2. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statute, regulations, or both. As with other guidance documents, FDA 
does not intend this guidance to be all-inclusive and cautions that not 
all information may be applicable to all situations. The guidance 
document is intended to

[[Page 71148]]

provide information and does not set forth requirements.

 II. Comments

     Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding the 
guidance document. Two copies of any comments are to be submitted, 
except individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the guidance document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

 III. Electronic Access

     Persons with access to the Internet may obtain the guidance 
document at http://www.fda.gov/cber/guidelines.htm.

    Dated: December 10, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-32789 Filed 12-17-99; 8:45 am]
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