[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44561-44562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15477]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0286]
Guidance for Industry: Class II Special Controls Guidance
Document: In Vitro Human Immunodeficiency Virus Drug Resistance
Genotype Assay; 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 document entitled ``Guidance for Industry: Class II
Special Controls Guidance Document: In Vitro HIV Drug Resistance
Genotype Assay,'' dated August 2007. The guidance document provides a
means by which in vitro human immunodeficiency virus (HIV) drug
resistance genotype assays may comply with special controls for class
II devices. Elsewhere in this issue of the Federal Register, FDA is
publishing a final rule classifying the in vitro HIV drug resistance
genotype assay into class II (special controls). The guidance announced
in this notice finalizes the draft guidance entitled ``Guidance for
Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special Controls'' dated August 2001.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the 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, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist the office
in processing your requests. The guidance may also be obtained by mail
by calling CBER at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit written comments on the guidance to the Division of Dockets
Management (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, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Class II Special Controls Guidance Document:
In Vitro HIV Drug Resistance Genotype Assay,'' dated August 2007. This
guidance document was developed as a special control to support
classification of the in vitro HIV drug resistance genotype assay from
class III to class II (special controls). Also, it is intended for use
in detecting HIV genomic mutations that confer resistance to specific
antiretroviral drugs as an aid in monitoring and treating HIV
infection.
In the Federal Register of August 29, 2001 (66 FR 45682), FDA
announced the availability of the draft guidance entitled ``Guidance
for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special Controls'' dated August 2001. FDA
received several comments on the draft guidance and those comments were
considered as the guidance was finalized. The guidance announced in
this notice finalizes the draft guidance entitled ``Guidance for
Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special Controls'' dated August 2001.
II. Significance of the Guidance
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. 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 statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E (regulations
governing premarket notification submissions) have been approved under
OMB control number 0910-0120.
IV. Comments
Interested persons may, at any time, submit written or electronic
comments to the Division of Dockets Management (see ADDRESSES)
regarding this guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in the brackets in the heading of this document. A copy of
the guidance and received comments are available for public examination
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
[[Page 44562]]
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15477 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S