[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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