
[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26805-26806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10390]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Chronic Hepatitis C Virus Infection: Developing Direct-Acting 
Antiviral Drugs for Treatment; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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the availability of a draft guidance for industry entitled ``Chronic 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 The purpose of this draft guidance is to assist 
sponsors in all phases of development of direct-acting antiviral (DAA) 
drugs for the treatment of chronic hepatitis C. This draft guidance 
revises the draft guidance of the same name that was issued on October 
23, 2013.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the

[[Page 26806]]

manner detailed (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1170 for ``Chronic Hepatitis C Virus Infection: Developing 
Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for 
Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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.

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.'' This draft guidance addresses 
nonclinical development, early phases of clinical development, and 
phase 3 protocol designs. Important issues addressed in this draft 
guidance include: Trial design options, noninferiority margin for 
active-controlled phase 3 trials in the evaluation of interferon (IFN)-
free regimens, and trial design options and safety evaluation for 
specific populations, including patients with decompensated cirrhosis, 
patients either pre- or post-liver transplant, patients with chronic 
kidney disease, and clinical virology considerations.
    This draft guidance revises the draft guidance of the same name 
that issued October 23, 2013 (78 FR 63218). Significant changes in this 
draft guidance compared to the previous version are:
     Modification of several sections to focus on IFN-free DAA 
regimens.
     Additional details on phase 2 and phase 3 trial design 
options for the evaluation of IFN-free regimens in treatment-na[iuml]ve 
and treatment-experienced populations, including DAA-experienced 
populations. Specifically, the guidance now recommends that each 
marketing application contain at least one active-controlled 
comparative trial.
     Additional clarification on DAA drug development in 
specific populations, including trial design options for human 
immunodeficiency virus/hepatitis C virus co-infected patients, 
pediatric patients, patients with advanced chronic kidney disease, 
patients with decompensated cirrhosis, patients either pre- or post-
liver transplantation, and patients who failed to respond to a prior 
DAA-based regimen.
    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 current thinking of FDA on developing DAA 
drugs for treatment of chronic hepatitis C virus infection. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it 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 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 0910-0014, the collections of information in 21 CFR part 314 have 
been approved under 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 
0910-0581.

III. Electronic Access

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

    Dated: April 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10390 Filed 5-3-16; 8:45 am]
 BILLING CODE 4164-01-P


