[Federal Register Volume 87, Number 67 (Thursday, April 7, 2022)]
[Notices]
[Pages 20431-20432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07397]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3903]


Chronic Hepatitis B Virus Infection: Developing 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 final guidance for industry entitled ``Chronic 
Hepatitis B Virus Infection: Developing Drugs for Treatment.'' The 
purpose of this guidance is to assist sponsors in the clinical 
development of drugs and biologics for the treatment of chronic 
hepatitis B virus (HBV) infection from the initial investigational new 
drug application (IND) through the new drug application (NDA)/biologics 
license application (BLA) and postmarketing phases. This guidance 
finalizes the draft guidance of the same title issued on November 2, 
2018.

DATES: The announcement of the guidance is published in the Federal 
Register on April 7, 2022.

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-2018-D-3903 for ``Chronic Hepatitis B Virus Infection: Developing 
Drugs for Treatment.'' 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, 240-
402-7500.
     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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

[[Page 20432]]

    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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 guidance document.

FOR FURTHER INFORMATION CONTACT: Poonam Mishra, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6100, Silver Spring, MD 20993, 301-796-
1500.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Chronic Hepatitis B Virus Infection: Developing Drugs for 
Treatment.'' The purpose of this guidance is to provide general 
recommendations on the clinical development of drugs and biologics for 
the treatment of chronic HBV infection from the initial IND through the 
NDA/BLA and postmarketing phases. The guidance includes general 
considerations for nonclinical toxicology and virology studies, early 
phase clinical development, clinical pharmacology assessments, and 
phase 3 safety and efficacy trials. The guidance discusses phase 3 
trial design considerations and efficacy endpoints for the development 
of finite duration therapies for the treatment of chronic HBV 
infection. Drug development considerations for specific subpopulations 
such as patients co-infected with hepatitis D virus or human 
immunodeficiency virus and for pediatric patients with chronic HBV 
infection are also included.
    This guidance finalizes the draft guidance of the same name issued 
on November 2, 2018 (83 FR 55187). FDA provided clarifying edits to the 
final guidance and included additional information after considering 
comments received on the draft guidance. Changes from the draft to the 
final guidance include the following: Considerations and 
recommendations for studies evaluating oligonucleotide-based 
investigational drugs, considerations for drugs developed to modulate 
innate and adaptive immune responses, updates to trial design 
considerations, updates to recommendations for safety monitoring 
(including monitoring for hepatitis flares after treatment 
discontinuation), and updates to efficacy extrapolation from adult to 
pediatric patients.
    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 B Virus Infection: 
Developing 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information for review of investigational new drug regulations in 21 
CFR part 312 have been approved under OMB control number 0910-0014, and 
the collections of information for review of new drug applications and 
biologic license applications in 21 CFR parts 314 and 601, have been 
approved under OMB control numbers 0910-0001 and 0910-0338, 
respectively. The collection of information regarding accelerated 
approval of serious conditions for drugs and biologics is approved 
under OMB control number 0910-0765. The collection of information 
regarding labeling of prescription drug and biologic products is 
approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07397 Filed 4-6-22; 8:45 am]
BILLING CODE 4164-01-P


