Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 72491 

numbers 0910–0308 and 0910–0291 

(Form FDA 3500A); the collections of 

information in part 601 have been 

approved under OMB control number 

0910–0338; the collections of 

information in FDA’s guidance entitled 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581; and, 

the collections of information in FDA’s 

guidance entitled ‘‘Emergency Use 

Authorization of Medical Products and 

Related Authorities’’ have been 

approved under OMB control number 

0910–0595. 

III. Emergency Use Authorization for 

Vaccines To Prevent COVID–19 

Guidance 

In October 2020, FDA first issued a 

guidance entitled ‘‘Emergency Use 

Authorization for Vaccines to Prevent 

COVID–19’’ (Vaccine EUA guidance) to 

provide sponsors of requests for 

emergency use authorization (EUA) for 

COVID–19 vaccines with 

recommendations regarding the data 

and information needed to support the 

issuance of an EUA under section 564 

of the FD&C Act (21 U.S.C. 360bbb–3) 

for an investigational vaccine to prevent 

COVID–19. Although, the guidance 

stated that it was intended to remain in 

effect only for the duration of the public 

health emergency related to COVID–19 

declared under the Public Health 

Service Act, in the Federal Register of 

March 13, 2023 (88 FR 15417 at 15421), 

FDA listed the guidance as one of the 

COVID–19-related guidances the 

Agency was revising to continue in 

effect for 180 days after the COVID–19 

public health emergency declared under 

the PHS Act expired on May 11, 2023, 

during which time FDA planned to 

further revise those guidances. 

However, circumstances have changed 

since the end of the declared public 

health emergency on May 11, 2023. FDA 

has reviewed the Vaccine EUA guidance 

and determined that the guidance is no 

longer needed, as the Agency has 

shifted its focus toward communicating 

directly with individual manufacturers. 

Accordingly, the EUA guidance will no 

longer be in effect after the publication 

of the guidance for immediate 

implementation announced in this 

notice, ‘‘Development and Licensure of 

Vaccines to Prevent COVID–19.’’ 

IV. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/emergency-preparednessand-response/coronavirus-disease-2019- 

covid-19/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: October 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23162 Filed 10–19–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2316] 

Benefit-Risk Assessment for New Drug 

and Biological Products; 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 ‘‘BenefitRisk Assessment for Human Drug and 

Biological Products.’’ FDA has 

developed this guidance document in 

accordance with goals associated with 

the sixth authorization of the 

Prescription Drug User Fee Act (PDUFA 

VI) under Title I of the FDA 

Reauthorization Act of 2017 and 

requirements under the 21st Century 

Cures Act. The intent of this guidance 

is to provide drug sponsors and other 

stakeholders with better clarity on how 

considerations about a drug’s benefits, 

risks, and risk management options 

factor into FDA’s pre- and postmarket 

regulatory decisions about new drug 

applications (NDAs) or biologics license 

applications (BLAs). This guidance 

finalizes the draft guidance of the same 

title issued in September 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 20, 2023. 

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– 

2020–D–2316 for ‘‘Benefit-Risk 

Assessment for New Drug and 

Biological Products.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
72492 Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 

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. 

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 this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research (CDER), Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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: 

Graham Thompson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–5003, 

Graham.Thompson@fda.hhs.gov; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Benefit-Risk Assessment for Human 

Drug and Biological Products.’’ This 

guidance articulates the key 

considerations that factor into CDER’s 

and CBER’s benefit-risk assessments, 

including how patient experience data 

may be used to inform benefit-risk 

assessment. It discusses how sponsors, 

through their decisions and activities 

throughout the drug lifecycle, can 

inform FDA’s benefit-risk assessment, as 

well as opportunities for interaction 

between FDA and sponsors to discuss 

benefit-risk considerations. It also 

discusses unique considerations for 

benefit-risk assessments that inform 

regulatory decision-making that occurs 

in the postmarket setting. 

Industry stakeholders have indicated 

having a clearer understanding of FDA’s 

decision-making context and benefitrisk considerations can help inform 

sponsors’ decisions about their drug 

development programs and the evidence 

they generate in support of their NDA or 

BLA. Patients and other stakeholders 

may gain further insight into the key 

issues that inform FDA’s assessment of 

benefit and risk, and a clearer 

understanding of how these issues fit 

into the regulatory framework of drug 

development and evaluation. 

This guidance finalizes the draft 

guidance entitled ‘‘Benefit-Risk 

Assessment for New Drug and 

Biological Products’’ issued on 

September 30, 2021 (86 FR 54211). FDA 

considered comments received on the 

draft guidance in developing the final 

guidance. Changes from the draft to the 

final guidance include clarifying 

language on FDA’s approach to benefitrisk assessment of new drugs and 

biologics, clarifying language on 

important considerations for FDA’s 

premarket benefit-risk assessment of 

drugs and biologics, clarifying language 

on activities that occur in premarket 

development that inform benefit-risk 

assessment, and other editorial changes. 

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 ‘‘Benefit-Risk 

Assessment for New Drug and 

Biological Products.’’ 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. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

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

3501–3521). The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001 as follows: (1) the 

content and format of investigational 

new drugs applications, (2) expanded 

access uses and treatment of patients 

with immediately life-threatening 

conditions or serious diseases or 

conditions, (3) regulatory requirements 

pertaining to postmarketing study 

commitments, and (4) risk evaluation 

and mitigation strategies pertaining to 

benefit-risk assessments. The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014 as follows: (1) the 

content and format of NDAs, (2) the 

submission of the patient population, 

(3) the submission of clinical trial data, 

and (4) benefit-risk planning, including 

early consultations with FDA meetings 

in end-of-phase 2 and pre-NDA 

meetings. The collections of information 

for good laboratory practices for 

nonclinical laboratory studies have been 

approved under OMB control number 

0910–0119. The collections of 

information for the submission of 

postmarketing adverse drug experience 

reporting have been approved under 

OMB control number 0910–0230. The 

collections of information in 21 CFR 

201.56 and 201.57 for the content and 

format requirements for labeling of 

drugs and biologics have been approved 

under OMB control number 0910–0572. 

The collections of information in the 

guidance for industry entitled 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ have 

been approved under OMB control 

number 0910–0765. The collections of 

information in the guidance for industry 

entitled ‘‘Providing Postmarket Periodic 

Safety Reports in the International 

Conference on Harmonisation E2C(R2) 

Format (Periodic Benefit-Risk 

Evaluation Report)’’ have been approved 

under OMB control number 0910–0230. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices 72493 

Dated: October 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23161 Filed 10–19–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: CAREWare 

Customer Satisfaction and Usage 

Survey 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than December 19, 

2023. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

CAREWare Customer Satisfaction and 

Usage Survey, OMB No. 0906–xxxx– 

New. 

Abstract: HRSA developed 

CAREWare, a software application first 

released in 2000, to help meet the data 

collection and reporting needs of Ryan 

White HIV/AIDS Program (RWHAP) 

grant recipients. The secure software is 

a free, electronic health and social 

support services information system for 

RWHAP grant recipients and their 

subrecipients to assist in the data 

requirement submissions that inform 

the development of the Ryan White 

HIV/AIDS Program Service Report, the 

AIDS Drug Assistance Program Data 

Report, the Ending the HIV Epidemic 

Initiative Triannual Report, and the 

voluntary Clinical Quality Measures 

Performance Measures. Over time, the 

software has evolved into a 

comprehensive health information 

system and is now the source of more 

than half of all the RWHAP client-level 

data received from recipients and 

subrecipients of RWHAP grant funding. 

CAREWare software manages HIV 

clinical and support service data from 

more than 360,000 client records in 48 

states; Washington, DC; Puerto Rico; 

and the U.S. Virgin Islands. 

The CAREWare software application 

contains customizable modules for 

tracking demographic information, 

services, medications, laboratory test 

results, immunization history, diagnoses 

(updated with International 

Classification of Diseases, Tenth 

Revision codes), referrals to outside 

agencies, and an appointment 

scheduler. There is a custom report 

generator and a performance measures 

module that supports quality of care 

initiatives at the provider level. The 

software also has several ways to import 

data from third-party sources, including 

commercial labs and other electronic 

health records (using both Health Level 

Seven and simple Comma Separated 

Value-formatted files), HIV surveillance 

systems, and for RWHAP Part B AIDS 

Drug Assistance Programs, pharmacy 

benefit programs. The software and user 

support materials can be accessed here: 

https://hab.hrsa.gov/program-grantsmanagement/careware. Finally, 

CAREWare supports users through an 

experienced helpdesk with ongoing 

software maintenance issues and 

enhancements to the user interface. 

HRSA is proposing a customer 

satisfaction survey to gather feedback 

from CAREWare users regarding their 

experiences and satisfaction with the 

software platform and to obtain 

suggestions for improvement. 

Need and Proposed Use of the 

Information: HRSA aims to understand 

CAREWare users’ needs and concerns 

by collecting information on current 

software features and inquiring about 

opportunities to improve the user 

experience and product features. The 

survey will address the software’s 

functionality and how well it meets the 

data collection, reporting, and quality 

management needs of the CAREWare 

user. The feedback will enable HRSA to 

assess, benchmark, and improve 

customer satisfaction with RWHAP 

grant recipients. 

Likely Respondents: RWHAP 

recipients and providers who use 

CAREWare to produce data files for the 

Ryan White HIV/AIDS Program Service 

Report, the AIDS Drug Assistance 

Program Data Report, the Ending the 

HIV Epidemic Initiative Triannual 

Report, and the voluntary Clinical 

Quality Measures performance measures 

module. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total Estimated Annualized Burden 

Hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

CAREWare User Survey ..................................................... 1,160 1 1,160 2 2,320 

Total .............................................................................. 1,160 1 1,160 2 2,320 


ddrumheller on DSK120RN23PROD with NOTICES1