[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63218-63219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1170]


Draft Guidance for Industry on Chronic Hepatitis C Virus 
Infection: Developing Direct-Acting Antiviral Drugs for Treatment; 
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availability of a draft guidance for industry entitled ``Chronic 
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs 
for Treatment.'' The purpose of this guidance is to assist sponsors in 
all phases of development of direct-acting antiviral (DAA) drugs for 
the treatment of chronic hepatitis C. This guidance revises and 
replaces a previous draft guidance for industry entitled ``Chronic 
Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents 
for Treatment'' issued on September 14, 2010.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 23, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Jeffrey Murray, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-
Acting Antiviral Drugs for Treatment.'' The purpose of this guidance is 
to assist sponsors in all phases of development of DAA drugs for the 
treatment of chronic hepatitis C. This guidance revises the draft 
guidance for industry entitled ``Chronic Hepatitis C Virus Infection: 
Developing Direct-Acting Antiviral Agents for Treatment'' issued in 
September 2010. Significant changes in this revision include:
     Details on phase 2 and phase 3 trial design options for 
the evaluation of interferon (IFN)-free and IFN-containing regimens in 
treatment-na[iuml]ve and treatment-experienced populations, including 
DAA-experienced populations.
     Revised primary endpoint to sustained virologic response 
at 12 weeks post-treatment cessation.
     Greater emphasis on DAA drug development in special 
populations including trial design options for human immunodeficiency 
virus/hepatitis C virus co-infected patients, patients with 
decompensated cirrhosis, and patients pre- or post-liver transplant.
     More details on clinical virology considerations for DAA 
drugs.

[[Page 63219]]

    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 developing 
DAA drugs for the treatment of chronic hepatitis C virus infection. 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 guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget 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, the collections of information in 
21 CFR part 314 have been approved under OMB control number 0910-0001, 
and the collections of information referred to in the guidance for 
industry ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under OMB control number 
0910-0581.

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: October 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24785 Filed 10-22-13; 8:45 am]
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