[Federal Register: August 29, 2001 (Volume 66, Number 168)]
[Notices]
[Page 45682-45683]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au01-70]
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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DATES: Submit written or electronic comments on the draft guidance to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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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for electronic access to the draft guidance document.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