[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12759-12760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0282; formerly 2005D-0183]


Draft Guidance for Industry on Attachment to Guidance on 
Antiviral Product Development--Conducting and Submitting Virology 
Studies to the Agency: Guidance for Submitting Hepatitis C Virus 
Resistance Data; 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availability of a draft guidance for industry entitled ``Attachment to 
Guidance on Antiviral Product Development--Conducting and Submitting 
Virology Studies to the Agency: Guidance for Submitting HCV Resistance 
Data.'' The purpose of this attachment is to assist sponsors in 
submitting hepatitis C virus (HCV) clinical virology data, which are 
important for supporting clinical trials of products in development for 
the treatment of HCV. HCV resistance data submitted in appropriately 
formatted datasets is a critical component in the review of 
investigational antiviral products for the treatment of HCV. The 
information in this attachment will facilitate the development and 
regulatory review of anti-HCV products.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 26, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY

[[Page 12760]]

INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa K. Naeger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-0771.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Attachment to Guidance on Antiviral Product Development--
Conducting and Submitting Virology Studies to the Agency: Guidance for 
Submitting HCV Resistance Data.'' The purpose of this attachment is to 
assist sponsors in submitting HCV clinical virology data, which are 
important for supporting clinical trials of products in development for 
the treatment of HCV. This attachment revises and replaces the 
attachment on submitting HCV resistance data published in June 2006 and 
represents FDA's current thinking regarding how sponsors should submit 
HCV resistance data. The revised attachment provides the format, 
recommended definitions, standardization of column headings and 
variables, and recommended data for submission of HCV resistance 
datasets.
    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 submitting 
HCV clinical virology data. 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. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information 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 collections of information in 21 CFR part 312 have been 
approved under OMB control number 0910-0014.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04196 Filed 2-22-13; 8:45 am]
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