[Federal Register Volume 66, Number 168 (Wednesday, August 29, 2001)]
[Notices]
[Pages 45682-45683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0286]


Draft ``Guidance for Industry: Premarket Notifications [510(k)s] 
for In Vitro HIV Drug Resistance Genotype Assays;'' Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 45683]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance 
Genotype Assays'' dated August 2001. In Vitro HIV Drug Resistance 
Genotype Assays are Class III devices that FDA is considering 
reclassifying as Class II, with special controls. This document 
describes such special controls, in draft, which would be intended to 
assist manufacturers of In Vitro HIV Drug Resistance Genotype Assays to 
file premarket notifications [510(k)s] instead of premarket approval 
applications (PMAs) for this device.

DATES: Submit written or electronic comments on the draft guidance to 
ensure their adequate consideration in preparation of the final 
document by October 29, 2001. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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 the 
office in processing your requests. The 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for electronic access to the draft guidance document.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 document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, 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 draft document entitled 
``Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro 
HIV Drug Resistance Genotype Assays'' dated August 2001. These devices 
are currently Class III devices. FDA is considering reclassification of 
HIV Drug Resistance Assays as Class II devices subject to special 
controls. After such reclassification, this guidance, when final, would 
serve as a special control for these devices.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This draft guidance 
document represents the agency's current thinking on special controls 
for HIV Drug Resistance Genotype Assays. 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 requirement of the applicable statutes and regulations.

II. Comments

    This draft 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 or 
electronic comments regarding this draft guidance document. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final document by October 29, 2001. 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 the 
brackets in the heading of this document. A copy of the 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 document at 
http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 20, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21734 Filed 8-28-01; 8:45 am]
BILLING CODE 4160-01-S