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). 


khammond on DSKJM1Z7X2PROD with NOTICES
9076 Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices 

ACTION: Request for information. 

SUMMARY: The Office of the Assistant 

Secretary for Health (OASH) in the 

Department of Health and Human 

Services seeks to obtain information 

regarding the current state of the science 

and technology to accelerate the pace of 

innovative solutions for the diagnosis of 

Lyme disease. A set of questions is 

available in the SUPPLEMENTARY

INFORMATION section below. 

DATES: To be considered, comments 

must be received electronically at the 

email address provided below, no later 

than 5:00 p.m. Eastern Time (ET) March 

15, 2021. 

ADDRESSES: Individuals are encouraged 

to submit responses electronically to Dr. 

Kristen Honey, Senior Advisor to the 

Assistant Secretary for Health, 200 

Independence Avenue SW, Washington, 

DC 20201, LymeInnovation@hhs.gov, 

(202) 853–7680. Please indicate ‘‘RFI 

RESPONSE’’ in the subject line of your 

email. Submissions received after the 

deadline will not be reviewed. 

Responses to this notice are not offers 

and cannot be accepted by the 

government to form a binding contract 

or issue a grant. Respond concisely and 

in plain language. You may use any 

structure or layout that presents the 

information well. You may respond to 

some or all of our questions, and you 

can suggest other factors or relevant 

questions. You may also include links to 

online material or interactive 

presentations. Clearly mark any 

proprietary information, and place it in 

its own section or file. Your response 

will become government property, and 

we may publish some of its nonproprietary content. 

SUPPLEMENTARY INFORMATION: The HHS 

Lyme Innovation initiative is a patientcentered, data-driven approach to the 

threat of Lyme disease and tick-borne 

diseases. Lyme disease affects more than 

300,000 people in the U.S. each year 

and accounts for more than 70% of all 

vector-borne diseases in our country. 

Lyme and other tick-borne diseases cost 

the U.S. economy billions of dollars 

annually. 

The HHS Lyme Innovation initiative 

uses strategic public-private 

partnerships to accelerate advancements 

in Lyme disease and other tick-borne 

diseases. The Lyme Innovation initiative 

aims to build commitment to patientcentered innovations, identify ways to 

collect and share data while raising 

awareness, accelerate the discovery of 

next-generation diagnostic tools and 

technologies, and lower barriers across 

all phases of development, testing, and 

implementation. The recommendations 

of the Tick-Borne Disease Working 

Group to HHS inform the Lyme 

Innovation initiative. The Lyme 

Innovation initiative represents one way 

that HHS is executing the strategies 

described in ‘‘A National Public Health 

Framework for the Prevention and 

Control of Vector-Borne Diseases in 

Humans.’’ 

HHS has entered into a public-private 

partnership with the Steven and 

Alexandra Cohen Foundation to form 

the LymeX Innovation Accelerator 

(LymeX). LymeX will accelerate the 

Lyme Innovation initiative’s progress 

and strategically advance tick-bornedisease solutions in direct collaboration 

with Lyme disease patients, patient 

advocates, and diverse stakeholders. A 

primary goal of the LymeX partnership 

and the Framework is the development 

of new diagnostic technologies for Lyme 

disease. 

The Centers for Disease Control and 

Prevention (CDC) website (https://

www.cdc.gov/lyme/index.html) 

summarizes information about the 

stages of Lyme disease, current 

diagnostic testing recommendations, 

and treatment options. CDC currently 

recommends the use of FDA cleared 

serologic tests in a two-step testing 

process that detects the presence of 

antibodies to Borrelia burgdorferi, the 

bacterium responsible for Lyme disease. 

Serologic tests for diagnosis of Lyme 

disease have technical limitations. 

Antibodies may not be produced by the 

immune system early enough or in high 

enough quantities to meet the detection 

limit of these tests (https://

www.hhs.gov/sites/default/files/tbdwgreport-to-congress-2018.pdf). As an 

antibody response in infected persons 

requires time to develop, serologic tests 

for Lyme disease may produce false 

negative results during early infection. 

In areas where Lyme disease is highly 

endemic, the infection may be 

diagnosed without laboratory testing if 

patients develop a diagnostic skin lesion 

at the site of the tick bite, which is 

known as erythema migrans (EM) or a 

‘‘bullseye rash.’’ However, 20% of 

patients may not develop this specific 

rash, and sometimes the rash is not seen 

or recognized. The rash also might not 

display the stereotypical presentation. 

Therefore, these newly infected patients 

may not be diagnosed in the absence of 

a sensitive diagnostic test and may not 

receive prompt or proper treatment for 

a disease with the potential to cause 

disabling illness. 

Serology tests are also not capable of 

determining if there is an active 

infection. As antibodies normally 

persist for months or even years after 

the infection is gone, serologic testing 

cannot be used to determine a cure. 

Additionally, cross-reactions between 

serologic tests for Lyme disease and 

those for other infectious diseases can 

also yield false positive results. 

These limitations of serological 

testing compound the scientific 

challenges in identifying specific 

etiologies for Post-Treatment Lyme 

Disease Syndrome (PTLDS), which is 

characterized by persistence of 

symptoms for more than 6 months 

following treatment with oral 

antibiotics. Improvements in Lyme 

disease diagnostics would enable better 

clinical management of PTLDS patients 

as well. 

HHS has identified an area of known 

need in developing more advanced 

diagnostic tests that diagnose infection 

at all stages of Lyme disease. Therefore, 

the LymeX partnership is embarking on 

a series of initiatives, including prize 

challenges to develop new diagnostic 

tests for Lyme disease. This RFI is 

intended to gather information on the 

current state of the science and 

development landscape for new 

diagnostic tests from the entrepreneurs, 

scientists, and physicians who will 

develop and use them. 

We encourage responders to answer 

the following questions: 

• What challenges/barriers exist for 

the development and validation of 

innovative diagnostic tests for Lyme 

disease? 

• What types of diagnostic 

technologies are being developed (or 

could be developed or adapted) to 

detect Lyme disease, including 

technologies and breakthroughs adapted 

from COVID–19 diagnostics with 

potential applications for Lyme disease 

(e.g., highly sensitive nucleic acid 

amplification testing [NAAT])? 

• What emerging technologies (e.g., 

epigenetic mapping, inflammatory 

markers, gene arrays, NAAT, or others) 

might be developed or adapted to 

characterize different stages of Lyme 

disease, including Post-Treatment Lyme 

Disease Syndrome (PTLDS), etc.? 

• What analyte (e.g., DNA, RNA, 

protein, metabolite) does existing or 

developing Lyme disease diagnostic 

tests detect? 

• What is the optimal sample type 

(e.g., whole blood, plasma) for the 

detection of a test analyte in patients 

with Lyme disease? The optimal sample 

type can be generally defined as the one 

where the analyte can be best detected. 

• What challenges exist in the 

implementation and use of Lyme 

disease diagnostic testing in clinical 

practice? 

• What role can or should publicprivate partnerships play in accelerating 


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Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices 9077 

development, validation, or appropriate 

use of innovative Lyme disease 

diagnostic tests, and what factors are 

most critical to ensure their success? 

This information will inform the 

development of the HHS Lyme 

Innovation initiative and the LymeX 

public-private partnership to create 

meaningful incentives to develop or 

validate new diagnostic tests for Lyme 

disease. 

Kristen Honey, 

Senior Advisor to the Assistant Secretary for 

Health (ASH), Office of the Assistant 

Secretary for Health, U.S. Department of 

Health and Human Service. 

[FR Doc. 2021–02796 Filed 2–10–21; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–xxxx] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before April 12, 2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990-New-60D, 

and project title for reference, to 

Sherrette Funn, Reports Clearance 

Officer, Sherrette.funn@hhs.gov, 202– 

795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

Title of the Collection: Family 

Planning Annual Report 2.0. 

Type of Collection: New. 

Abstract: The Office of Population 

Affairs (OPA), within the Office of the 

Assistant Secretary for Health, seeks 

approval for a new encounter level data 

collection for the Family Planning 

Annual Report (FPAR). Currently 

collected in aggregate under OMB No. 

0990–0221, this new data collection, 

‘‘FPAR 2.0’’, will collect information at 

the encounter level and build on the 

existing data collection and reporting 

system. This annual reporting 

requirement is for competitively 

awarded grants authorized and funded 

by the Title X Family Planning Program. 

Need and Proposed Use of the 

Information: The Office of Population 

Affairs’ (OPA) Title X Family Planning 

Program is the only federal grant 

program dedicated solely to providing 

comprehensive family planning and 

related preventive health services. 

Annual submission of the FPAR is 

required of all Title X family planning 

services grantees for purposes of 

monitoring and reporting program 

performance (45 CFR part 74 and 45 

CFR part 92). The FPAR is the only 

source of annual, uniform reporting by 

all grantees funded under Section 1001 

of the Title X Public Health Service Act. 

Similar to the previous FPAR, FPAR 2.0 

will provide consistent, national-level 

data on the Title X Family Planning 

program and its users. OPA will be able 

to assemble and analyze comparable 

and relevant program data to answer 

questions about the characteristics of 

the population served, the provision 

and use of services, and the impact of 

the program on certain family planning 

outcomes. FPAR 2.0 will also collect a 

standard set of data elements pertaining 

to users and encounters, such as user 

demographics, service delivery, family 

planning intentions and methods, and 

other indicators, which allow for 

comparisons over time at all levels of 

the program (e.g., national, regional, 

state, and grantee). Encounter level data 

collected through FPAR 2.0 will 

ultimately improve the quality of data 

reported to OPA and reduce reporting 

burden by grantees. Additionally, the 

more granular data collected with FPAR 

2.0 will help contribute to a learning 

healthcare environment by greatly 

expanding the options for data analysis 

and reporting—for example, through 

interactive data dashboards and 

visualizations, customized tabulations 

and reports, and application of analytics 

and statistical analyses on the 

encounter-level data files. 

Information from FPAR 2.0 is 

important to OPA for many reasons, and 

will be used to: 

(1) Monitor compliance with statutory 

requirements, regulations, and 

operational guidance. 

(2) Comply with accountability and 

federal performance requirements for 

Title X family planning funds. 

(3) Guide strategic and financial 

planning, to monitor performance, to 

respond to inquiries from policymakers 

and Congress about the program, and to 

estimate program impact. 

Type of respondent: Annual reporting; 

respondents are all grantees that receive 

Title X funding from OPA. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

FPAR 2.0 .......................................... Grantees ........................................... 74 1 36 2,664 

Total ........................................... ........................................................... ........................ 1 ........................ 2,664 


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