[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37402-37403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18403]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft ``Guidance for Industry: In the Manufacture and Clinical 
Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human 
Immunodeficiency Virus Type 1;'' 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availability of a draft guidance document entitled ``Guidance for 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.'' The draft guidance document addresses general and specific 
concerns for gene based detection techniques, and it is intended to 
provide 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, however, comments 
should be submitted by October 8, 1998, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests 
to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 
1'' 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

[[Page 37403]]

that office in processing your requests. The draft guidance document 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit written comments on the draft guidance document to the 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, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
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.'' The draft guidance document outlines 
some of the major regulatory and scientific issues concerning gene 
based tests for Human Immunodeficiency Virus (HIV), these criteria also 
apply to tests for other transfusion transmitted viruses including 
Human Immunodeficiency Virus Type 2, Hepatitis C Virus, Hepatitis B 
Virus, Human T-cell Lymphotropic Virus Types I and II.
    This draft 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 type 1. 
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 draft guidance document to be all-inclusive and 
cautions that not all information may be applicable to all situations. 
The draft guidance document is intended to provide information and does 
not set forth requirements.

II. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (address 
above) written comments regarding the draft guidance document. Written 
comments may be submitted at any time; however, comments should be 
submitted by October 8, 1998, to ensure adequate consideration in 
preparation of the final guidance document. Two copies of any comments 
are to be submitted, except individuals may submit one copy. Comments 
should be identified with the docket number found in brackets in the 
heading of this document. A copy of the draft 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 draft guidance 
document using the World Wide Web (WWW). For WWW access, connect to 
CBER at ``http://www.fda.gov/cber/guidelines.htm''.

    Dated: June 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18403 Filed 7-9-98; 8:45 am]
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