61602 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

regulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These 

guidance documents are also available 

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

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘Evidentiary 

Expectations for 510(k) Implant 

Devices’’ (document number 

GUI00020017), ‘‘Recommendations for 

the Use of Clinical Data in Premarket 

Notification [510(k)] Submissions’’ 

(document number GUI00020016), or 

‘‘Best Practices for Selecting a Predicate 

Device to Support a Premarket 

Notification [510(k)] Submission’’ 

(document number GUI00020006) may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

new collection of information, they do 

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 

the following table have been approved 

by OMB: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E .......................................... Premarket notification .................................................................................................. 0910–0120 

‘‘Requests for Feedback and Meetings for 

Medical Device Submissions: The QSubmission Program’’.

Q-Submissions and Early Payor Feedback Request Programs for Medical Devices 0910–0756 

800, 801, 809, and 830 ............................ Medical Device Labeling Regulations; Unique Device Identification ........................... 0910–0485 

803 ............................................................ Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting.0910–0437 

810 ............................................................ Medical Device Recalls ................................................................................................ 0910–0432 

820 ............................................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... 0910–0073 

822 ............................................................ Postmarket Surveillance of Medical Devices ............................................................... 0910–0449 

Forms FDA 3500 and FDA 3500A ........... Medical device adverse event reporting—MedWatch ................................................. 0910–0291 

58 .............................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies ..... 0910–0119 

Dated: September 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19283 Filed 9–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Public Comment Request; 

Information Collection Request Title: 

Health Professions Student Loan 

Program, Loans for Disadvantaged 

Students Program, Primary Care Loan 

Program, and Nursing Student Loan 

Program Administrative Requirements, 

OMB No. 0915–0047—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for the 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: 

Health Professions Student Loan (HPSL) 

Program, Loans for Disadvantaged 

Students (LDS) Program, Primary Care 

Loan (PCL) Program, and Nursing 

Student (Loan (NSL) Program 

Administrative Requirements, OMB No. 

0915–0047—Revision. 

Abstract: This clearance request is for 

approval of the HPSL Program, LDS 

Program, PCL Program, and NSL 

Program Administrative Requirements. 

The HPSL Program, authorized by 

Public Health Service (PHS) Act 

sections 721–722 and 725–735, is a 

grant program where recipients provide 

long-term, low-interest loans to students 

attending schools of medicine, 

osteopathic medicine, dentistry, 

veterinary medicine, optometry, 

podiatric medicine, and pharmacy. The 

LDS Program, authorized by PHS Act 

sections 721–722 and 724–735, is a 

grant program where recipients provide 

long-term, low interest loans to certain 

students attending schools of allopathic 

medicine, osteopathic medicine, 

podiatric medicine, dentistry, 

optometry, pharmacy, and veterinary 

medicine. The PCL Program, authorized 

by PHS Act sections 721–723 and 725– 

735, is a grant program where recipients 

provide long-term, low interest loans to 

students attending schools of allopathic 

medicine and osteopathic medicine to 

practice primary health care. The NSL 

Program, authorized by PHS Act 

sections 835–842, is a grant program 

where recipients provide long-term, 

low-interest loans to students who 

attend eligible schools of nursing in 

programs leading to a diploma degree, 

an associate degree, a baccalaureate 

degree, or a graduate degree in nursing. 

These programs also have a number of 

recordkeeping and reporting 

requirements for academic institutions 

and loan applicants. The applicable 

program regulations are found in 42 

CFR 57.201–218 and 57.301–318. HRSA 

proposes revisions to the Annual 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 61603 

Operating Report (AOR)–HRSA Form 

501 completed by institutions 

participating in the HPSL, LDS, PCL, 

and NSL programs to obtain additional 

information about those institutions and 

their student borrowers. 

Need and Proposed Use of the 

Information: Participating HPSL, LDS, 

PCL, and NSL schools are responsible 

for determining the eligibility of 

applicants, making loans, and collecting 

monies owed by borrowers on their 

outstanding loans. Participating schools 

include schools that are no longer 

disbursing loans but are required to 

report and maintain program records, 

student records, and repayment records 

until all student loans are repaid in full, 

and all monies due to the federal 

government are returned. The 

Deferment Form—HRSA Form 519, 

provides the schools with 

documentation of a borrower’s 

deferment status, as detailed for the 

HPSL program under 42 CFR 57.210 and 

NSL under 42 CFR 57.310, and is 

included with minor revisions. The 

proposed revisions to the AOR are to 

modify the options selected for gender 

identification consistent with Executive 

Order 14075—Executive Order on 

Advancing Equality for Lesbian, Gay, 

Bisexual, Transgender, Queer, and 

Intersex Individuals. 

Additionally, the deferment form is 

being updated to provide specific 

directions for the submission 

requirements to notify students that the 

deferment request must be submitted to 

the institution 30 days prior to the 

payment due date. The institution must 

respond to the student 30 days after 

receipt of the student request. 

• Likely Respondents: Institutions 

who have received HPSL, LDS, PCL, 

and/or NSL Program awards. 

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

Instrument 

(HPSL, LDS, 

PCL, & NSL) 

Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total 

burden 

hours 

Deferment—HRSA Form 519 .................................................................. 2,060 1 2,060 .50 1,030 

AOR–HRSA—Form 501 .......................................................................... 726 1 726 12.00 8,712 

Total .................................................................................................. 2,786 .................... 2,786 .................... 9,742 

Grand Total (instruments and record-keeping reporting requirements) ............................................................................ .................... .................... .................... .................... 327,979 

RECORDKEEPING REQUIREMENTS

Data required to be submitted 

Number of 

record 

keepers 

Hours 

per year 

Total burden 

hours 

HPSL, LDS, and PCL Program: 

Documentation of Cost of Attendance ................................................................................. 432 1.05 454 

Promissory Note ................................................................................................................... 432 1.25 540 

Documentation of Entrance Interview .................................................................................. 432 1.25 540 

Documentation of Exit Interview ........................................................................................... * 475 0.37 176 

Program Records ................................................................................................................. * 475 10.00 4,750 

Student Records ................................................................................................................... * 475 10.00 4,750 

Repayment Records ............................................................................................................. * 475 19.55 9,286 

HPSL/LDS/PCL Subtotal ............................................................................................... 475 ........................ 20,496 

NSL Program: 

Documentation of Cost of Attendance ................................................................................. 304 0.25 76

Promissory Note ................................................................................................................... 304 0.50 152 

Documentation of Entrance Interview .................................................................................. 304 0.50 152 

Documentation of Exit Interview ........................................................................................... * 486 0.14 68 

Program Records ................................................................................................................. * 486 5.00 2,430 

Student Records ................................................................................................................... * 486 1.00 486 

Repayment Records ............................................................................................................. * 486 2.51 1,220 

NSL Subtotal ................................................................................................................. 486 ........................ 4,584 

* Includes active and closing schools. 

REPORTING REQUIREMENTS

Number of 

respondents 

Responses 

per 

respondent 

Total 

annual 

responses 

Hours per 

response 

Total burden 

hours 

HPSL, LDS, and PCL: 


ddrumheller on DSK120RN23PROD with NOTICES1
61604 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

REPORTING REQUIREMENTS—Continued 

Number of 

respondents 

Responses 

per 

respondent 

Total 

annual 

responses 

Hours per 

response 

Total burden 

hours 

Student Financial Aid Transcript .................................. 4,600 1 4,600 0.25 1,150 

Loan Information Disclosure ......................................... 325 299.5 97,338 0.63 61,323 

Entrance Interview ........................................................ 325 139.5 45,338 0.50 22,669 

Exit Interview ................................................................ * 334 113.5 37,909 1.00 37,909 

Notification of Repayment ............................................ * 334 862.5 288,075 0.38 109,469 

Notification During Deferment ...................................... * 333 17 5,661 0.63 3,566 

Notification of Delinquent Accounts .............................. 334 172.5 57,615 1.25 72,019 

Credit Bureau Notification ............................................. 334 6 2,004 0.50 1,002 

Write-off of Uncollectable Loans .................................. 520 1 520 3.00 1,560 

Disability Cancellation ................................................... 3 1 3 1.00 3 

Administrative Hearings record retention ..................... 0 0 0 0.00 0 

Administrative Hearings reporting requirements .......... 0 0 0 0.00 0 

HPSL Subtotal ....................................................... ........................ ........................ ........................ ........................ 310,670 

NSL: 

Student Financial Aid Transcript .................................. 4,100 1 4,100 0.25 1,025 

Entrance Interview ........................................................ 282 17.5 4,935 0.42 2,073 

Exit Interview ................................................................ 348 9 3,132 0.42 1,315 

Notification of Repayment ............................................ 348 9 3,132 0.27 846 

Notification During Deferment ...................................... 348 1.5 522 0.29 151 

Notification of Delinquent Accounts .............................. 348 42.5 14,790 0.04 592 

Credit Bureau Notification ............................................. 348 709 246,732 0.06 1,480 

Write-off of Uncollectable Loans .................................. 23 1 23 3.00 69 

Disability Cancellation ................................................... 16 1 16 1.00 16 

Administrative Hearings ................................................ 0 0 0 0.00 0 

NSL Subtotal ......................................................... ........................ ........................ ........................ ........................ 7,567 

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. 2023–19203 Filed 9–6–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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 of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; RFA–DK–22–028 

Pilot and Feasibility R01s to Integrate Soc 

and Med Care in Type 1 Diabetes. 

Date: October 12, 2023. 

Time: 12:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

NIDDK, Democracy II, Suite 7000A, 6707 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Cheryl Nordstrom, Ph.D., 

MPH, Scientific Review Officer, NIDDK/ 

Scientific Review Branch, National Institutes 

of Health, 6707 Democracy Blvd., Room 

7013, Bethesda, MD 20892, 301–402–6711, 

cheryl.nordstrom@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: August 31, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–19260 Filed 9–6–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 of 

Dental and Craniofacial Research Special 


ddrumheller on DSK120RN23PROD with NOTICES1