[Federal Register Volume 71, Number 107 (Monday, June 5, 2006)]
[Notices]
[Pages 32351-32352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0183]


Guidance for Industry on Antiviral Product Development--
Conducting and Submitting Virology Studies to the Agency; 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 for industry entitled ``Antiviral Product 
Development--Conducting and Submitting Virology Studies to the 
Agency.'' The purpose of this guidance is to assist sponsors in 
developing and submitting nonclinical and clinical virology data, which 
are important to support clinical trials of antiviral products. 
Nonclinical and clinical virology reports are essential components in 
the review of investigational antiviral products. The information in 
this guidance will facilitate the development of antiviral products.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6367, Silver Spring, MD 20993-0002, 301-
796-1500, or Julian O'Rear, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 
6368, Silver Spring, MD 20993-0002, 301-796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Antiviral Product Development--Conducting and Submitting 
Virology Studies to the Agency.'' The purpose of this guidance is to 
assist sponsors in the development of antiviral products and to serve 
as a starting point for understanding the nonclinical and clinical 
virology data important to support clinical trials of antiviral 
products. This guidance focuses on nonclinical and clinical virology 
studies, which are essential components in the review of 
investigational antiviral products. Topics in this guidance include 
studies defining the mechanism of action, establishing specific 
antiviral activity of the investigational product, assessing the 
potential for antagonism of other antiviral products that might be used 
in combination with the investigational product, providing data on the 
development of viral resistance to the investigational product, and 
providing data that identify cross-resistance to approved products 
having the same target.
    The guidance announced in this document finalizes the draft 
guidance entitled ``Antiviral Drug Development--Conducting Virology 
Studies and Submitting the Data to the Agency'' that was announced in 
the Federal Register of May 25, 2005 (70 FR 30127). The sample formats 
that were included as appendixes in the draft guidance have been 
removed from the guidance and are now included as stand-alone 
documents. A fourth format for assisting sponsors in the submission of 
influenza data has been added. These sample formats will be updated as 
needed, and additional formats for other viruses may be provided.
    This 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 conducting virology studies and submitting 
the data and reports to the agency. 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.

II. 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-

[[Page 32352]]

3520). The collections of information have been approved under OMB 
control number 0910-0014.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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 brackets 
in the heading of this document. The guidance and received comments may 
be seen 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 document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8635 Filed 6-2-06; 8:45 am]
BILLING CODE 4160-01-S