[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Draft Guidance for Industry on Chronic Hepatitis C Virus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availability of a draft guidance for industry entitled ``Chronic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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 15, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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