58284 Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Notices 

Act of 2023 (Pub. L. 117–328); see also 21 CFR 

314.510. 

withdrawal of approval is warranted 

because the required post-approval 

confirmatory trial failed to verify 

clinical benefit and because available 

evidence demonstrates PEPAXTO is not 

shown to be safe or effective under its 

conditions of use. The Oncologic Drugs 

Advisory Committee (ODAC) convened 

on September 22, 2022, to discuss issues 

related to this proposed withdrawal. 

The ODAC voted 14 to 2 that the 

benefit-risk profile of melphalan 

flufenamide was not favorable for the 

currently indicated patient population. 

For additional background, please refer 

to CDER’s letter to Oncopeptides Re: 

Section 506(c)(3)(B) Notice of Proposed 

Withdrawal of Approval; PEPAXTO 

(melphalan flufenamide) for injection; 

NDA 214383 (‘‘Notice to Oncopeptides 

of Proposed Withdrawal of PEPAXTO’’) 

and CDER’s Proposed Withdrawal of 

PEPAXTO Decisional Memorandum, 

available at Docket No. FDA–2023–N– 

3167, https://www.regulations.gov. 

II. Legal Standard for Withdrawal of 

Approval 

Section 506(c) of the FD&C Act, as 

amended most recently by the 

Consolidated Appropriations Act of 

2023 (Pub. L. 117–328), describes the 

accelerated approval of new drug 

applications and the procedures and 

authority governing expedited 

withdrawal of approval. FDA has the 

legal authority to use the expedited 

procedures to withdraw approval of a 

product that has received accelerated 

approval if, among other reasons, ‘‘a 

study required to verify and describe the 

predicted effect on irreversible 

morbidity or mortality or other clinical 

benefit of the product fails to verify and 

describe such effect or benefit’’ (section 

506(c)(3)(A)(ii) of the FD&C Act) or 

‘‘other evidence demonstrates that the 

product is not shown to be safe or 

effective under the conditions of use.’’ 

(section 506(c)(3)(A)(iii) of the FD&C 

Act.) 

III. Explanation for the Proposed 

Withdrawal 

CDER proposes to withdraw approval 

of PEPAXTO because the required 

confirmatory study, Trial OP–103, also 

known as OCEAN, failed to verify 

clinical benefit and because available 

evidence demonstrates PEPAXTO is not 

shown to be safe or effective under its 

conditions of use. More specifically, the 

results failed to show that PEPAXTO 

had a significant effect on the primary 

endpoint of progression-free survival. 

Furthermore, the observed median 

overall survival was 5.3 months shorter 

in the PEPAXTO arm compared to the 

control arm. After considering all the 

available data and the discussion at the 

ODAC held in September 2022, CDER 

recommends withdrawing the 

accelerated approval for PEPAXTO. 

Please refer to CDER’s ‘‘Notice to 

Oncopeptides of Proposed Withdrawal 

of PEPAXTO’’ and ‘‘Proposed 

Withdrawal of PEPAXTO Decisional 

Memorandum’’ for additional 

explanation. 

IV. Opportunity for Public Comment on 

CDER’s Proposal To Withdraw 

Approval of PEPAXTO 

In accordance with the expedited 

withdrawal of approval procedures 

described in section 506(c)(3)(B)(ii) and 

(iii) of the FD&C Act, CDER is providing 

an opportunity for public comment on 

its proposal to withdraw approval of 

NDA 214383 (PEPAXTO) through the 

issuance of a Federal Register Notice. 

FDA will consider any such public 

comments it receives in making its 

decision on CDER’s proposal to 

withdraw approval of NDA 214383 

(PEPAXTO) and make available on its 

website and in the public docket a 

summary of such comments and FDA’s 

response to them. 

Dated: August 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18320 Filed 8–24–23; 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: Standardized 

Work Plan Form for Use With 

Applications to the Bureau of Health 

Workforce Research and Training 

Grants and Cooperative Agreements 

OMB No. 0906–0049—Extension 

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 October 24, 2023. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 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: 

Standardized Work Plan (SWP) Form for 

Use with Applications to the Bureau of 

Health Workforce (BHW) Research and 

Training Grants and Cooperative 

Agreements OMB No. 0906–0049— 

Extension. 

Abstract: BHW requires applicants for 

training and research grants and 

cooperative agreements to submit work 

plans via the SWP form. Information in 

the SWP describes the timeframes and 

progress required during the grant 

period of performance to address each 

of the needs detailed in the Purpose and 

Need section of the application, as 

required in the Notice of Funding 

Opportunity announcement. Applicants 

use the SWP form when they submit 

their proposals, and award recipients 

and Project Officers use the SWP 

information to assist in monitoring 

progress once HRSA makes the awards. 

After awards are made, recipients 

complete a Quarterly Progress Update 

(QPU) to provide information to BHW 

on a quarterly basis on each activity 

listed in the SWP. 

Need and Proposed Use of the 

Information: Information collected by 

the SWP form and QPUs standardizes 

and streamlines the data used by HRSA 

in reviewing applications and 

monitoring awardees. The form asks 

applicants to provide a description of 

the activities or steps the applicant will 

take to achieve each of the objectives 

proposed during the entire period of 

performance. The current standardized 

format and data submission by 

applicants increases efficiency in 

reviewing, awarding, and monitoring 

each project. 

The QPU is completed via HRSA’s 

Electronic Handbook system and 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 164 / Friday, August 25, 2023 / Notices 58285 

prompts recipients to report on progress 

of activities that were submitted using 

the SWP in the original application. The 

QPU automatically populates activities 

from the recipient’s SWP form on a 

quarterly basis. For each activity listed 

in the submitted SWP for any particular 

quarter within the project period, 

recipients select and submit a single 

selection response for each activity 

status from a pull-down menu with five 

options: Activity is on Schedule, 

Activity is Complete, Timing is off 

track, Activity will be missed if action 

is not taken, and Activity cannot be 

achieved. Information provided is 

utilized by the program staff to regularly 

assess overall progress of program 

requirements and analyze data in order 

to monitor award recipient compliance 

and track progress against proposed 

targets and goals. Information gathered 

allows an improved and more efficient 

method for identifying whether projects’ 

goals are being advanced or achieved, as 

set forth in 45 CFR 75.342. Program staff 

also use information provided over the 

period of performance to see emerging 

trends and to assess whether an award 

recipient requires technical assistance to 

address challenges that the award 

recipient may be experiencing with the 

implementation of the project. Seeking 

OMB extension approval comports with 

the regulatory requirement imposed by 

45 CFR 75.206(a), Paperwork clearances. 

Likely Respondents: Respondents are 

applicants for, and recipients of, BHW’s 

research and training grants and 

cooperative agreements. 

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 annual 

burden hours 

Standardized Work Plan (SWP) .......................................... 1,000 1 1,000 1.00 1,000 

Quarterly Progress Update (QPU) Form ............................. 1,000 4 4,000 .10 400 

Total .............................................................................. 1 1,000 ........................ 5,000 ........................ 1,400 

1The 1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active grants. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–18360 Filed 8–24–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Initial Review Group; Career 

Development for Established Investigators 

and Conference Grants Study Section. 

Date: October 26–27, 2023. 

Time: 10:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Rajasri Roy, Ph.D., M.P.H., 

Scientific Review Officer, Scientific Review 

Branch, National Institutes of Health, 

National Institute on Aging, 7201 Wisconsin 

Avenue, RM: 2W200, Bethesda, MD 20892, 

301–496–6477, rajasri.roy@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 21, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–18380 Filed 8–24–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, National Institute on 

Alcohol Abuse and Alcoholism. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), title 5 U.S.C., as amended for 

the review, discussion, and evaluation 

of individual intramural programs and 

projects conducted by the National 

Institute on Alcohol Abuse and 

Alcoholism, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Board of Scientific 

Counselors, National Institute on Alcohol 

Abuse and Alcoholism. 

Date: September 13–14, 2023. 

Time: 9:00 a.m. to 5:00 p.m. 


ddrumheller on DSK120RN23PROD with NOTICES1