Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 60693 

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 312 for the 

submissions of investigational new drug 

applications, including clinical trial 

design and study protocols, have been 

approved under OMB control number 

0910–0014. The collections of 

information in 21 CFR part 314 

pertaining to the submissions of new 

drug applications have been approved 

under OMB control number 0910–0001. 

The collections of information in 21 

CFR part 601 pertaining to the 

submissions of biologics license 

applications have been approved under 

OMB control number 0910–0338. 

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: August 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19060 Filed 9–1–23; 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: Faculty Loan 

Repayment Program OMB No. 0915– 

0150—Revision 

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 November 6, 

2023. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 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: 

Faculty Loan Repayment Program OMB 

No. 0915–0150—Revision 

Abstract: HRSA administers the 

Faculty Loan Repayment Program 

(FLRP). FLRP provides health 

professionals from disadvantaged 

backgrounds based on environmental 

and/or economic factors the opportunity 

to enter into a contract with the 

Department of Health and Human 

Services to receive repayment of 

qualifying educational loans in 

exchange for a minimum of 2 years of 

service as a full-time or part-time faculty 

member at an eligible health professions 

school. The applicant completes and 

submits an electronic application that 

identifies for the Secretary of Health and 

Human Services that the applicant 

comes from an economically or 

environmentally disadvantaged 

background who has a contract with an 

eligible health professions school to 

serve as a full-time or part-time faculty 

member for a minimum of 2 years and 

has qualifying outstanding educational 

loans. In addition, for each 

undergraduate and/or graduate loan for 

which repayment is sought, the 

applicant is required to submit loan 

documentation verifying the 

establishment of the educational loan(s) 

and lender account statements, 

promissory notes including the original 

date, and current balance of the 

outstanding educational loan(s). The 

sole change in this version of the ICR 

from previous ICR versions is that there 

is an increase in the estimated burden 

hours related to an increased number of 

respondents/applicants to the FLRP. 

Need and Proposed Use of the 

Information: The information collected 

will be used to evaluate applicants’ 

eligibility to participate in the FLRP and 

to monitor FLRP related activities. 

Likely Respondents: FLRP applicants 

and institutions providing employment 

to the applicants. 

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 

Eligible Applications ............................................................. 215 1 215 1.00 215.00 


ddrumheller on DSK120RN23PROD with NOTICES1
60694 Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Institution/Loan Repayment Employment Form .................. * 215 1 215 1.00 215.00 

Authorization to Release Information Form ......................... 215 1 215 .25 53.75 

Disadvantaged Background Form ....................................... 215 1 215 .20 43.00 

Total .............................................................................. 860 526.75 

* Respondents for this form is the institution on behalf of the applicant. 

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. 2023–19054 Filed 9–1–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Office of Infectious Disease and 

HIV/AIDS Policy, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) hereby gives notice that 

the National Vaccine Advisory 

Committee (NVAC) will hold an inperson meeting. The meeting will be 

open to the public and public comment 

will be heard during the meeting. 

DATES: The meeting will be held 

September 21–22, 2023. The confirmed 

meeting times and agenda will be 

posted on the NVAC website at http:// 

www.hhs.gov/nvpo/nvac/meetings/ 

index.html as soon as they become 

available. 

ADDRESSES: Instructions regarding 

attending this meeting will be posted 

online at: http://www.hhs.gov/nvpo/ 

nvac/meetings/index.html at least one 

week prior to the meeting. Preregistration is required for those who 

wish to attend the meeting in person or 

participate in public comment. Please 

register at http://www.hhs.gov/nvpo/ 

nvac/meetings/index.html. 

FOR FURTHER INFORMATION CONTACT: Ann 

Aikin, Acting Designated Federal 

Officer, Office of Infectious Disease and 

HIV/AIDS Policy, U.S. Department of 

Health and Human Services, Tower 

Building, Room, 1101 Wootton 

Parkway, Rockville, MD 20852. Email: 

nvac@hhs.gov. Phone: 202–795–7697. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 2101 of the Public Health 

Service Act (42 U.S.C. 300aa–1), the 

Secretary of HHS was mandated to 

establish the National Vaccine Program 

to achieve optimal prevention of human 

infectious diseases through 

immunization and to achieve optimal 

prevention against adverse reactions to 

vaccines. The NVAC was established to 

provide advice and make 

recommendations to the Director of the 

National Vaccine Program on matters 

related to the Program’s responsibilities. 

The Assistant Secretary for Health 

serves as Director of the National 

Vaccine Program. 

During this meeting, NVAC will hear 

presentations to support the recent 

charges on innovation and safety from 

Admiral Rachel L. Levine, MD, the 

Assistant Secretary for Health and 

Director of the National Vaccine 

Program. NVAC will also hear 

presentations on the actions and 

strategies taken to better address the 

unique vaccination needs of people 

with disabilities, respiratory disease 

prevention plans for the upcoming fall 

season, and updates on climate change 

vaccines. Please note that agenda items 

are subject to change, as priorities 

dictate. Information on the final meeting 

agenda will be posted prior to the 

meeting on the NVAC website: http://

www.hhs.gov/nvpo/nvac/index.html. 

Members of the public will have the 

opportunity to provide comment at the 

NVAC meeting during the public 

comment period designated on the 

agenda. Public comments made during 

the meeting will be limited to three 

minutes per person to ensure time is 

allotted for all those wishing to speak. 

Members of the public may also submit 

written comments. Written comments 

should not exceed three pages in length. 

Individuals planning to submit 

comments should email their written 

comments or their request to provide a 

comment during the meeting to nvac@

hhs.gov at least five business days prior 

to the meeting. 

Dated: August 7, 2023. 

Ann Aikin, 

Acting Designated Federal Official, Office of 

the Assistant Secretary for Health. 

[FR Doc. 2023–18994 Filed 9–1–23; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Ivana Frech, Ph.D. (formerly Ivana De 

Domenico) (Respondent), former 

Assistant Professor, Department of 

Internal Medicine, University of Utah 

(UU) School of Medicine. Respondent 

engaged in research misconduct in 

research supported by U.S. Public 

Health Service (PHS) funds, specifically 

National Institute of Diabetes and 

Digestive and Kidney Diseases (NIDDK), 

National Institutes of Health (NIH), 

grants R01 DK070947, R01 DK090257, 

and R01 DK030534, National Institute of 

General Medical Sciences (NIGMS), 

NIH, grant P50 GM082545, National 

Institute of Allergy and Infectious 

Diseases (NIAID), NIH, grant R01 

AI051174, and National Heart, Lung, 

and Blood Institute (NHLBI), NIH, grant 

R01 HL026922. The administrative 

actions, including debarment for a 

period of three (3) years, were 

implemented beginning on August 21, 

2023, and are detailed below. 


ddrumheller on DSK120RN23PROD with NOTICES1