[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availability of a draft guidance document entitled ``Guidance for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 The draft guidance document addresses general and specific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 The draft guidance document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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit written comments on the draft guidance document to the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]
BILLING CODE 4160-01-F
