Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20431 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) ........................................................................... 62 1 62 2 124 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Notification of emergency use—814.124(a) ....................................................... 22 1 22 1 22 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

increase of 360 total burden hours and 

a corresponding increase of five total 

annual responses. For efficiency of 

Agency operations, we are consolidating 

the related information activity and 

account for burden associated with HDE 

regulations currently approved in OMB 

control number 0910–0661. As a result, 

there is an increase in the total number 

of burden hours for this information 

collection. 

Dated: March 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07376 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
20432 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

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/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–N–1529, FDA– 

2014–D–0609, FDA–2012–N–0961, FDA– 

2021–N–1022, FDA–2018–N–4130, and FDA– 

2018–N–3037] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 


khammond on DSKJM1Z7X2PROD with NOTICES