Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices 9073 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/advisory-committees and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before joining the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will meet in open session to 

discuss EUA of the Janssen Biotech Inc. 

COVID–19 Vaccine for active 

immunization to prevent COVID–19 

caused by SARS–CoV–2 in individuals 

18 years and older. EUA authority 

allows FDA to help strengthen the 

nation’s public health protections 

against chemical, biological, 

radiological, nuclear (CBRN) threats by 

facilitating the availability and use of 

Medical Countermeasures (MCMs) 

needed during public health 

emergencies. Under section 564 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360bbb–3), FDA may allow 

unapproved medical products or 

unapproved uses of approved medical 

products to be used in an emergency to 

diagnose, treat, or prevent serious or 

life-threatening diseases or conditions 

caused by CBRN threat agents when 

certain statutory criteria have been met, 

including that there are no adequate, 

approved, and available alternatives. 

Additional information about EUAs can 

be found at https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/emergency-useauthorization. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, background material will be 

made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

advisory-committees/advisorycommittee-calendar. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

February 18, 2021, will be provided to 

the committee. Comments received after 

February 18, 2021, and by February 25, 

2021, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 1:25 p.m. Eastern Time 

and 2:25 p.m. Eastern Time. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before February 17, 2021. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 18, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Prabhakara 

Atreya or Kathleen Hayes 

(CBERVRBPAC@fda.hhs.gov) at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at: 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–02845 Filed 2–10–21; 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, 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 (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than March 15, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Health Professions Student Loan (HPSL) 

Program, Loans for Disadvantaged 

Students, Primary Care Loan Program 

(PCL), and Nursing Student Loan 

Program Administrative Requirements. 

OMB No. 0915–0047—Revision 

Abstract: This clearance request is for 

approval of the Health Professions 

Student Loan (HPSL) Program, Loans for 

Disadvantaged Students (LDS), Primary 

Care Loan Program (PCL), and Nursing 

Student Loan (NSL) Program 


khammond on DSKJM1Z7X2PROD with NOTICES
9074 Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices 

Administrative Requirements. The form 

was previously titled as the HPSL 

Program and NSL Program 

Administrative Requirements 

(Regulations and Policy). This request 

seeks to add LDS and PCL as the forms 

discussed in this notice are also used for 

these programs. 

The HPSL Program, as authorized by 

Public Health Service (PHS) Act 

sections 721–722 and 725–735, provides 

long-term, low-interest loans to students 

attending schools of medicine, 

osteopathic medicine, dentistry, 

veterinary medicine, optometry, 

podiatric medicine, and pharmacy. The 

LDS Program, as authorized by PHS Act 

sections 721–722 and 724–735, provides 

long-term, low interest loans to students 

attending schools of allopathic 

medicine, osteopathic medicine, 

podiatric medicine, dentistry, 

optometry, pharmacy, and veterinary 

medicine. The PCL Program, as 

authorized by PHS Act sections 721–723 

and 725–735, provides long-term, low 

interest loans to students attending 

schools of allopathic medicine and 

osteopathic medicine to practice 

primary health care. The NSL Program, 

as authorized by PHS Act sections 835– 

842, provides 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 requirements for these 

programs are outlined in 42 CFR 

57.201–218 and 57.301–318. HRSA 

proposes revisions to the Annual 

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. 

A 60-day notice published in the 

Federal Register on December 14, 2020, 

vol. 85, No. 240; pp. 80791–93. There 

were no public comments. 

Need and Proposed Use of the 

Information: Participating HPSL, LDS, 

PCL, and NSL schools are responsible 

for determining 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 

for NSL under 42 CFR 57.310, and is 

included without revision. 

The AOR–HRSA Form 501 provides 

HHS with information from 

participating schools relating to HPSL, 

LDS, PCL and NSL program operations 

and financial activities. The proposed 

revisions to the AOR include the 

addition of a part-time option to select 

questions to allow institutions to report 

data on their part-time students, who 

are eligible to receive funding through 

the NSL program. 

Specifically, the ‘‘part-time’’ option 

will be added to the following questions 

for the NHL program: 

• Question 3, page 1A of the non-PCL 

section of the AOR (total full-time 

enrollment for the Nursing discipline 

for the academic year¥NSL loan 

recipients), 

• Question 13 (total number of full 

time graduates¥NSL loan recipients) at 

the school during the current reporting 

period), 

• Question 14 (total number of full 

time NSL graduates¥NSL loan 

recipients) during the current reporting 

period who indicate intent to serve in a 

rural area), 

• Question 15b (of the total graduates 

reported in question 15a, the number of 

full-time NSL graduates¥NSL loan 

recipients in academic year 20XX–20XX 

serving in medically underserved 

communities), 

• Question 15c (of the total graduates 

reported in question 15a, the number of 

Full-Time NSL graduates—NSL loan 

recipients in academic year 20XX— 

20XX serving in primary care), and 

• Question 15d (of the total graduates 

in question 15a, the number of full-time 

NSL graduates¥NSL loan recipients in 

Academic Year 20XX–20XX who 

entered the field for which they 

received their degree). 

HRSA also proposes to revise the 

AOR–HRSA Form 501 form to include 

four additional questions at the bottom 

of Page 1A of all AORs: 

• 16a. Are you a Community College? 

• 16b. Are you a Historically Black 

College or University? 

• 16c. Are you a Tribal college or 

university? and 

• 16d. Are you an institution located 

in a rural area? 

In addition, HRSA proposes to revise 

Page 4 (the excess cash worksheet) of 

the AOR–HRSA Form 501 form to limit 

the grantees’ ability to make projections 

to 1 year. This proposed revision will 

allow HRSA to improve the overall 

management of funding. 

Likely Respondents: Institutions 

participating in the HPSL, LDS, PCL, 

and/or NSL Programs. 

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 .............................................. 2060 1 2060 .5 1,030 

AOR–HRSA—Form 501 ...................................................... 726 1 726 12 8,712 

Total .............................................................................. 2786 ........................ 2786 ........................ 9,742 

Grand Total (instruments and recordkeeping requirements) ........................................................ ........................ ........................ ........................ ........................ 327,979 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices 9075 

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: 

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 1560 

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. 2021–02807 Filed 2–10–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information (RFI): 

Accelerating Innovation in Diagnostic 

Testing for Lyme Disease 

AGENCY: Office of the Assistant 

Secretary for Health (OASH), Office of 

the Secretary, Department of Health and 

Human Services (HHS). 


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