[Federal Register: May 25, 2005 (Volume 70, Number 100)]
[Notices]               
[Page 30127-30128]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25my05-124]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0183]

 
Draft Guidance for Industry on Antiviral Drug Development--
Conducting Virology Studies and Submitting the Data 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availability of a draft guidance for industry entitled ``Antiviral Drug 
Development--Conducting Virology Studies and Submitting the Data to the 
Agency.'' This guidance is being issued to assist sponsors in 
developing and submitting nonclinical and clinical virology data, which 
are important to support clinical trials of antiviral agents. 
Nonclinical and clinical virology reports are essential components in 
the review of investigational antiviral drugs. The information in this 
guidance will facilitate the development of antiviral drug products.

DATES: Submit written or electronic comments on the draft guidance by 
July 25, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug 
Evaluation and Research (HFD-530), Food and Drug Administration, 9201 
Corporate Blvd., Rockville, MD 20857, 301-827-2330; or Julian O'Rear, 
Center for Drug Evaluation and Research (HFD-530), Food and Drug 
Administration, 9201 Corporate Blvd., Rockville, MD 20857, 301-827-
2330.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Antiviral Drug Development--Conducting Virology Studies and 
Submitting the Data to the Agency.'' The purpose of this guidance is to 
assist sponsors in the development of antiviral drug products and to 
serve as a starting point for understanding the nonclinical and 
clinical virology data important to support clinical trials of 
antiviral agents. This guidance focuses on nonclinical and clinical 
virology studies, which are essential components in the review of

[[Page 30128]]

investigational antiviral drugs. Topics in this guidance include 
studies defining the mechanism of action, establishing specific 
antiviral activity of the investigative drug, providing data on the 
development of viral resistance to the investigational drug, and 
providing data identifying cross-resistance to approved drugs having 
the same target.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on antiviral 
drug development; conducting virology studies and submitting the data 
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 contains information collection provisions that 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 
collection of information in this guidance was approved under OMB 
control number 0910-0014 (until January 31, 2006).

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft 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 brackets 
in the heading of this document. The draft 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 document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
    Dated: May 18, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10431 Filed 5-24-05; 8:45 am]

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