[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in this notice finalizes the draft guidance entitled ``Guidance for 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