[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55797-55798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22806]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0462]


Draft Guidance for Industry on Chronic Hepatitis C Virus 
Infection: Developing Direct-Acting Antiviral Agents 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availability of a draft guidance for industry entitled ``Chronic 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 Agents 
for Treatment.'' The purpose of this guidance is to assist sponsors in 
all phases of development of direct-acting antiviral agents (DAAs), 
defined as agents that interfere with specific steps in the hepatitis C 
virus (HCV) replication cycle. The guidance outlines the types of 
nonclinical studies and clinical trials recommended throughout the drug 
development process to support approval of treatments for chronic 
hepatitis C (CHC), including in patients with compensated and 
decompensated cirrhosis and those co-infected with human 
immunodeficiency virus (HIV). The guidance also addresses pre-approval 
access in the form of treatment investigational new drug applications 
(INDs) and intermediate-sized safety protocols.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 15, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

[[Page 55798]]


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 Agents for Treatment.'' This draft guidance addresses 
nonclinical development, early phases of clinical development, phase 3 
protocol designs, and endpoints for the treatment of CHC, including in 
patients who are treatment na[iuml]ve or experienced, patients without 
cirrhosis, patients with compensated and decompensated cirrhosis, and 
patients co-infected with HCV and HIV. Important issues addressed in 
this guidance include: Drug development methods to reduce the emergence 
of drug resistance, types of trial designs to assess optimal dose and 
treatment duration, combination therapy with multiple investigational 
drugs, recommendations on development of drugs to meet unmet medical 
needs, and use of treatment INDs or other smaller safety protocols to 
provide early access of multiple DAAs for patients at risk of imminent 
progression of liver disease.
    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 
DAAs for treatment of CHC 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 (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, 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 ``Establishment and Operation of Clinical Trial Data 
Monitoring Committees'' have been approved under OMB control number 
0910-0581.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: September 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22806 Filed 9-13-10; 8:45 am]
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