82 FR 51636 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

Page Range		51636-51637
FR Document		2017-24195

The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance finalizes the draft guidance of the same name issued on May 4, 2016.

Federal Register, Volume 82 Issue 214 (Tuesday, November 7, 2017)

[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51636-51637]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-24195]

[[Page 51636]]

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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; 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 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the treatment of chronic hepatitis C. This guidance finalizes the draft
guidance of the same name issued on May 4, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on November 7, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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; Guidance for Industry;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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 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 guidance for industry
entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-
Acting Antiviral Drugs for Treatment.'' This guidance addresses
nonclinical development, early phases of clinical development, and
phase 3 protocol designs. Important issues addressed in this guidance
include: trial design options, choice of noninferiority margins for
active-controlled phase 3 trials in the evaluation of interferon (IFN)-
free regimens, and trial design options and safety evaluations for
specific populations including patients with decompensated cirrhosis,
patients either pre- or post-liver transplant, and patients with
chronic kidney disease and clinical virology considerations. This
guidance finalizes the draft guidance of the same name issued on May 4,
2016 (81 FR 26805). Changes made to the guidance took into
consideration comments received. In addition to editorial changes
primarily for clarification, the major changes are as follows:
Modification of several sections to focus on IFN-free DAA
regimens.
Additional clarification on trial designs for combinations
of investigational DAAs with or without ribavirin.
Additional clarification on the recommended trial
population to

[[Page 51637]]

include patients with clinical or laboratory evidence of chronic
hepatitis C disease, such as the presence of fibrosis by biopsy or
noninvasive tests.
Additional details on DAA drug development in patients
with decompensated cirrhosis, including recommendations for a review by
an independent adjudication committee for all serious hepatic events,
deaths, liver transplantations, and changes in prespecified alanine
transaminase, aspartate transaminase, and bilirubin parameters and a
recommendation for long-term followup to characterize clinical outcomes
such as progression or regression of liver disease, liver-related
mortality, occurrence of hepatocellular carcinoma, or liver failure
requiring liver transplantation.
Additional clarification on efficacy endpoints,
specifically additional post-treatment followup (e.g., 1 year or
longer) may be needed if one or more drugs in the regimen has a long
plasma or intracellular half-life or prolonged antiviral activity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Chronic Hepatitis C Virus Infection:
Developing Direct-Acting Antiviral Drugs for Treatment.'' 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. This guidance
is not subject to Executive Order 12866.

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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

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

Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24195 Filed 11-6-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51637

include patients with clinical or DEPARTMENT OF HEALTH AND provisions set forth in sections
laboratory evidence of chronic hepatitis HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
C disease, such as the presence of as amended. The grant applications and
fibrosis by biopsy or noninvasive tests. National Institutes of Health the discussions could disclose
• Additional details on DAA drug confidential trade secrets or commercial
development in patients with National Heart, Lung, and Blood
property such as patentable material,
decompensated cirrhosis, including Institute; Notice of Closed Meeting
and personal information concerning
recommendations for a review by an Pursuant to section 10(d) of the individuals associated with the grant
independent adjudication committee for Federal Advisory Committee Act, as applications, the disclosure of which
all serious hepatic events, deaths, liver amended, notice is hereby given of the would constitute a clearly unwarranted
transplantations, and changes in following Heart, Lung, & Blood Program invasion of personal privacy.
prespecified alanine transaminase, Project Review Committee meeting.
aspartate transaminase, and bilirubin The meeting will be closed to the Name of Committee: Center for Scientific
parameters and a recommendation for public in accordance with the Review Special Emphasis Panel; PAR Panel:
long-term followup to characterize Synthetic Psychoactive Drugs and Strategic
provisions set forth in sections
clinical outcomes such as progression or Approaches to Counteract their Deleterious
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
regression of liver disease, liver-related Effects.
as amended. The grant applications and
mortality, occurrence of hepatocellular Date: November 30, 2017.
the discussions could disclose
carcinoma, or liver failure requiring Time: 1:00 p.m. to 6:00 p.m.
confidential trade secrets or commercial
liver transplantation. Agenda: To review and evaluate grant
property such as patentable material,
• Additional clarification on efficacy applications.
and personal information concerning Place: National Institutes of Health, 6701
endpoints, specifically additional post- individuals associated with the grant
treatment followup (e.g., 1 year or Rockledge Drive, Bethesda, MD 20892
applications, the disclosure of which (Virtual Meeting).
longer) may be needed if one or more would constitute a clearly unwarranted Contact Person: Jasenka Borzan, Ph.D.,
drugs in the regimen has a long plasma invasion of personal privacy. Scientific Review Officer, Center for
or intracellular half-life or prolonged
Name of Committee: Heart, Lung, and Scientific Review, National Institutes of
antiviral activity. Blood Initial Review Group; Heart, Lung, and Health, 6701 Rockledge Drive, Room 4214,
This guidance is being issued Blood Program Project Review Committee. MSC 7814, Bethesda, MD 20892–7814, 301–
consistent with FDA’s good guidance Date: December 1, 2017. 435–1787, borzanj@csr.nih.gov.
practices regulation (21 CFR 10.115). Time: 8:00 a.m. to 2:00 p.m.
The guidance represents the current Agenda: To review and evaluate grant Name of Committee: Center for Scientific
thinking of FDA on ‘‘Chronic Hepatitis applications. Review Special Emphasis Panel; Member
C Virus Infection: Developing Direct- Place: Sheraton BWI (Baltimore), 1100 Old Conflict: Neuroimmunology,
Elkridge Landing Road, Baltimore, MD Neuroinflammation and Brain Tumor.
Acting Antiviral Drugs for Treatment.’’ 21090.
It does not establish any rights for any Date: December 6, 2017.
Contact Person: Jeffrey H. Hurst, Ph.D., Time: 10:00 a.m. to 2:00 p.m.
person and is not binding on FDA or the Scientific Review Officer, Office of Scientific Agenda: To review and evaluate grant
public. You can use an alternative Review/DERA, National Heart, Lung, and
applications.
approach if it satisfies the requirements Blood Institute, National Institutes of Health,
6701 Rockledge Drive, Room 7208, Bethesda, Place: National Institutes of Health, 6701
of the applicable statutes and
MD 20892, 301–435–0303, hurstj@ Rockledge Drive, Bethesda, MD 20892
regulations. This guidance is not subject
nhlbi.nih.gov. (Telephone Conference Call).
to Executive Order 12866.
(Catalogue of Federal Domestic Assistance Contact Person: Nataliya Gordiyenko,
II. The Paperwork Reduction Act of Program Nos. 93.233, National Center for Ph.D., Scientific Review Officer, Center for
1995 Sleep Disorders Research; 93.837, Heart and Scientific Review, National Institutes of
Vascular Diseases Research; 93.838, Lung Health, 6701 Rockledge Drive, Room 5202,
This guidance refers to previously Diseases Research; 93.839, Blood Diseases MSC 7846, Bethesda, MD 20892, 301–435–
approved collections of information that and Resources Research, National Institutes 1265, gordiyenkon@csr.nih.gov.
are subject to review by the Office of of Health, HHS)
Management and Budget (OMB) under Name of Committee: Center for Scientific
Dated: November 1, 2017. Review Special Emphasis Panel; Member
the Paperwork Reduction Act of 1995 Michelle Trout,
(44 U.S.C. 3501–3520). The collections Conflict: Retinal Synapses and Circuitry.
Program Analyst, Office of Federal Advisory Date: December 6, 2017.
of information in 21 CFR parts 312 and Committee Policy.
314 have been approved under OMB Time: 12:00 p.m. to 4:00 p.m.
[FR Doc. 2017–24144 Filed 11–6–17; 8:45 am] Agenda: To review and evaluate grant
control numbers 0910–0014 and 0910–
BILLING CODE 4140–01–P applications.
0001, respectively.
Place: National Institutes of Health, 6701
III. Electronic Access Rockledge Drive, Bethesda, MD 20892
Persons with access to the internet DEPARTMENT OF HEALTH AND (Telephone Conference Call).
may obtain the guidance at either HUMAN SERVICES Contact Person: Afia Sultana, Ph.D.,
https://www.fda.gov/Drugs/Guidance Scientific Review Officer, National Institutes
National Institutes of Health of Health, Center for Scientific Review, 6701
ComplianceRegulatoryInformation/
Rockledge Drive, Room 4189, Bethesda, MD
Guidances/default.htm or https:// Center for Scientific Review; Notice of 20892, (301) 827–7083, sultanaa@
www.regulations.gov.
ethrower on DSK3G9T082PROD with NOTICES

Closed Meetings mail.nih.gov.
Dated: November 2, 2017. Pursuant to section 10(d) of the (Catalogue of Federal Domestic Assistance
Anna K. Abram, Federal Advisory Committee Act, as Program Nos. 93.306, Comparative Medicine;
Deputy Commissioner for Policy, Planning, amended, notice is hereby given of the 93.333, Clinical Research, 93.306, 93.333,
Legislation, and Analysis. following meetings. 93.337, 93.393–93.396, 93.837–93.844,
[FR Doc. 2017–24195 Filed 11–6–17; 8:45 am] The meetings will be closed to the 93.846–93.878, 93.892, 93.893, National
BILLING CODE 4164–01–P public in accordance with the Institutes of Health, HHS)

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Document Created: 2018-10-25 10:25:59
Document Modified: 2018-10-25 10:25:59

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on November 7, 2017.
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.
FR Citation		82 FR 51636

82 FR 51636 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration