81_FR_26891 81 FR 26805 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Availability

81 FR 26805 - Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 86 (May 4, 2016)

Page Range26805-26806
FR Document2016-10390

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This draft guidance revises the draft guidance of the same name that was issued on October 23, 2013.

Federal Register, Volume 81 Issue 86 (Wednesday, May 4, 2016) 
[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26805-26806]
From the Federal Register Online  [www.thefederalregister.org]
[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Antiviral Drugs for Treatment; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Chronic 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 The purpose of this draft guidance is to assist 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drugs for the treatment of chronic hepatitis C. This draft guidance 
revises the draft guidance of the same name that was issued on October 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 5, 2016.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

Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices 26805 ACTION: Notice of public workshop. arthritis will be presented and DEPARTMENT OF HEALTH AND discussed. HUMAN SERVICES SUMMARY: The Food and Drug Administration (FDA), in collaboration FDA has verified the Web site Food and Drug Administration with the University of Maryland Center addresses in this document, but FDA is not responsible for subsequent changes [Docket No. FDA–2013–D–1170] of Excellence in Regulatory Science and Innovation (CERSI), is announcing a to the Web site after this document publishes in the Federal Register. Chronic Hepatitis C Virus Infection: public workshop entitled ‘‘Quantitative Developing Direct-Acting Antiviral Assessment of Assumptions to Support Agenda: The agenda is located at Drugs for Treatment; Draft Guidance Extrapolation of Efficacy in Pediatrics.’’ www.pharmacy.umaryland.edu/ for Industry; Availability The objective of the workshop is to PedsExtrapolation. discuss quantitative and qualitative AGENCY: Food and Drug Administration, Registration: There is a registration fee HHS. approaches for verifying assumptions to attend this public workshop in ACTION: Notice of availability. pertaining to disease and therapeutic person. Seats are limited and response similarity between adults and registration will be on a first-come, first- SUMMARY: The Food and Drug children. The workshop will also served basis. To register, please Administration (FDA or Agency) is provide a forum for discussion on the complete registration online at announcing the availability of a draft use of modeling and simulation for www.pharmacy.umaryland.edu/ guidance for industry entitled ‘‘Chronic systematic assessment of extrapolation PedsExtrapolation. There will be no Hepatitis C Virus Infection: Developing assumptions. onsite registration. The costs of Direct-Acting Antiviral Drugs for DATES: The public workshop will be registration, to attend in person, for the Treatment.’’ The purpose of this draft held on June 1, 2016, from 8 a.m. to 5 different categories of attendees are as guidance is to assist sponsors in all p.m. follows: phases of development of direct-acting ADDRESSES: The public workshop will antiviral (DAA) drugs for the treatment be held at FDA’s White Oak Campus, Category Cost of chronic hepatitis C. This draft 10903 New Hampshire Ave., Building guidance revises the draft guidance of 31 Conference Center, the Great Room Industry Representative .................... $50 the same name that was issued on (Rm. 1503), Silver Spring, MD 20993. Nonprofit Organization and Aca- October 23, 2013. Entrance for the public meeting demic other than University of DATES: Although you can comment on participants (non-FDA employees) is Maryland ....................................... 50 any guidance at any time (see 21 CFR through Building 1 where routine University of Maryland, College Park 10.115(g)(5)), to ensure that the Agency security check procedures will be and Baltimore ................................ 0 considers your comment on this draft performed. For parking and security Federal Government ......................... 0 guidance before it begins work on the information, please refer to http:// final version of the guidance, submit www.fda.gov/AboutFDA/ Streaming Webcast of the Public either electronic or written comments WorkingatFDA/BuildingsandFacilities/ Workshop: This public workshop will on the draft guidance by July 5, 2016. WhiteOakCampusInformation/ also be Webcast. There is no registration ADDRESSES: You may submit comments ucm241740.htm. fee for access to the workshop via the as follows: FOR FURTHER INFORMATION CONTACT: Webcast, but registration is still Electronic Submissions Audrey Thomas, Office of Regulatory required. Information regarding access to the Webcast link is available at Submit electronic comments in the Science and Innovation, Office of the following way: Chief Scientist, Food and Drug www.pharmacy.umaryland.edu/ PedsExtrapolation. If you have never • Federal eRulemaking Portal: http:// Administration, 10903 New Hampshire www.regulations.gov. Follow the Ave., Bldg. 1, Rm. 4220, Silver Spring, attended a Connect Pro event before, instructions for submitting comments. MD 20993–0002, 301–796–3520, test your connection at https:// Comments submitted electronically, Audrey.Thomas@fda.hhs.gov. collaboration.fda.gov/common/help/en/ including attachments, to http:// SUPPLEMENTARY INFORMATION: The support/meeting_test.htm. To get a www.regulations.gov will be posted to purpose of this public workshop is to quick overview of the Connect Pro the docket unchanged. Because your provide an opportunity for relevant program, visit http://www.adobe.com/ comment will be made public, you are stakeholders, including clinicians, go/connectpro_overview. solely responsible for ensuring that your academia, industry, and FDA to discuss Accommodations: Attendees are comment does not include any systematic assessment of data needed to responsible for their own hotel confidential information that you or a support extrapolation of efficacy in accommodations. If you need special third party may not wish to be posted, pediatric product development. accommodations while at FDA’s White such as medical information, your or Specifically, the workshop will include: Oak Campus due to a disability, please anyone else’s Social Security number, or (1) Presentations on approaches for contact Shari Solomon at confidential business information, such assessing disease and therapeutic Shari.Solomon@fda.hhs.gov at least 7 as a manufacturing process. Please note response similarity between adults and days in advance. that if you include your name, contact pediatrics, and (2) discussion of information, or other information that asabaliauskas on DSK3SPTVN1PROD with NOTICES alternative approaches to the assessment Dated: April 26, 2016. identifies you in the body of your of extrapolation assumptions in Leslie Kux, comments, that information will be pediatric product development, Associate Commissioner for Policy. posted on http://www.regulations.gov. including the use of clinical trial [FR Doc. 2016–10397 Filed 5–3–16; 8:45 am] • If you want to submit a comment simulation and Bayesian approaches. BILLING CODE 4164–01–P with confidential information that you Examples in partial onset seizures, do not wish to be made available to the inflammatory bowel diseases, and public, submit the comment as a polyarticular juvenile idiopathic written/paper submission and in the VerDate Sep<11>2014 18:44 May 03, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1

26806 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Notices manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ DAA-experienced populations. Submissions’’ and ‘‘Instructions’’). default.htm. Specifically, the guidance now Docket: For access to the docket to recommends that each marketing Written/Paper Submissions read background documents or the application contain at least one active- Submit written/paper submissions as electronic and written/paper comments controlled comparative trial. follows: received, go to http:// • Additional clarification on DAA • Mail/Hand delivery/Courier (for www.regulations.gov and insert the drug development in specific written/paper submissions): Division of docket number, found in brackets in the heading of this document, into the populations, including trial design Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts options for human immunodeficiency Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets virus/hepatitis C virus co-infected • For written/paper comments Management, 5630 Fishers Lane, Rm. patients, pediatric patients, patients submitted to the Division of Dockets 1061, Rockville, MD 20852. with advanced chronic kidney disease, Management, FDA will post your Submit written requests for single patients with decompensated cirrhosis, comment, as well as any attachments, copies of the draft guidance to the patients either pre- or post-liver except for information submitted, Division of Drug Information, Center for transplantation, and patients who failed marked, and identified, as confidential, Drug Evaluation and Research, Food to respond to a prior DAA-based if submitted as detailed in and Drug Administration, 10001 New regimen. ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, This draft guidance is being issued Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– consistent with FDA’s good guidance must include the Docket No. FDA– 0002. Send one self-addressed adhesive practices regulation (21 CFR 10.115). 2013–D–1170 for ‘‘Chronic Hepatitis C label to assist that office in processing The draft guidance, when finalized, will Virus Infection: Developing Direct- your requests. See the SUPPLEMENTARY represent the current thinking of FDA Acting Antiviral Drugs for Treatment; INFORMATION section for electronic on developing DAA drugs for treatment Draft Guidance for Industry; access to the draft guidance document. of chronic hepatitis C virus infection. It Availability.’’ Received comments will FOR FURTHER INFORMATION CONTACT: does not establish any rights for any be placed in the docket and, except for Jeffrey Murray, Center for Drug person and is not binding on FDA or the those submitted as ‘‘Confidential Evaluation and Research, Food and public. You can use an alternative Submissions,’’ publicly viewable at Drug Administration, 10903 New approach if it satisfies the requirements http://www.regulations.gov or at the Hampshire Ave., Bldg. 22, Rm. 6360, of the applicable statutes and Division of Dockets Management Silver Spring, MD 20993–0002, 301– between 9 a.m. and 4 p.m., Monday 796–1500. regulations. through Friday. SUPPLEMENTARY INFORMATION II. The Paperwork Reduction Act of • Confidential Submissions—To 1995 submit a comment with confidential I. Background information that you do not wish to be FDA is announcing the availability of This draft guidance refers to made publicly available, submit your a draft guidance for industry entitled previously approved collections of comments only as a written/paper ‘‘Chronic Hepatitis C Virus Infection: information that are subject to review by submission. You should submit two Developing Direct-Acting Antiviral the Office of Management and Budget copies total. One copy will include the Drugs for Treatment.’’ This draft under the Paperwork Reduction Act of information you claim to be confidential guidance addresses nonclinical 1995 (44 U.S.C. 3501–3520). The with a heading or cover note that states development, early phases of clinical collections of information in 21 CFR ‘‘THIS DOCUMENT CONTAINS development, and phase 3 protocol part 312 have been approved under CONFIDENTIAL INFORMATION.’’ The designs. Important issues addressed in 0910–0014, the collections of Agency will review this copy, including this draft guidance include: Trial design information in 21 CFR part 314 have the claimed confidential information, in options, noninferiority margin for been approved under 0910–0001, and its consideration of comments. The active-controlled phase 3 trials in the the collections of information referred to second copy, which will have the evaluation of interferon (IFN)-free in the guidance for industry claimed confidential information regimens, and trial design options and ‘‘Establishment and Operation of redacted/blacked out, will be available safety evaluation for specific Clinical Trial Data Monitoring for public viewing and posted on populations, including patients with Committees’’ have been approved under http://www.regulations.gov. Submit decompensated cirrhosis, patients either 0910–0581. both copies to the Division of Dockets pre- or post-liver transplant, patients Management. If you do not wish your with chronic kidney disease, and III. Electronic Access name and contact information to be clinical virology considerations. made publicly available, you can This draft guidance revises the draft Persons with access to the Internet provide this information on the cover guidance of the same name that issued may obtain the draft guidance at either sheet and not in the body of your October 23, 2013 (78 FR 63218). http://www.fda.gov/Drugs/Guidance comments and you must identify this Significant changes in this draft ComplianceRegulatoryInformation/ information as ‘‘confidential.’’ Any guidance compared to the previous Guidances/default.htm or http:// asabaliauskas on DSK3SPTVN1PROD with NOTICES information marked as ‘‘confidential’’ version are: www.regulations.gov. will not be disclosed except in • Modification of several sections to Dated: April 28, 2016. accordance with 21 CFR 10.20 and other focus on IFN-free DAA regimens. Leslie Kux, applicable disclosure law. For more • Additional details on phase 2 and information about FDA’s posting of phase 3 trial design options for the Associate Commissioner for Policy. comments to public dockets, see 80 FR evaluation of IFN-free regimens in [FR Doc. 2016–10390 Filed 5–3–16; 8:45 am] 56469, September 18, 2015, or access treatment-naı̈ve and treatment- BILLING CODE 4164–01–P the information at: http://www.fda.gov/ experienced populations, including VerDate Sep<11>2014 18:44 May 03, 2016 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 E:\FR\FM\04MYN1.SGM 04MYN1


Document Created: 2016-05-04 01:23:07
Document Modified: 2016-05-04 01:23:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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.
ContactJeffrey 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 Citation81 FR 26805 
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