36550 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 

and other STDs; and (6) advance the 

education of health professionals and 

the public from HIV, viral hepatitis, and 

other STDs. 

The CDC/HRSA Advisory Committee 

on HIV and STD Prevention and 

Treatment meets at least two times each 

calendar year, or at the discretion of the 

Designated Federal Officer in 

consultation with the CHACHSPT cochairs. 

The CDC/HRSA Advisory Committee 

on HIV and STD Prevention and 

Treatment shall advise the Director, 

CDC, and the Administrator, HRSA, 

regarding objectives, strategies, policies, 

and priorities for HIV, viral hepatitis, 

and other STD prevention and treatment 

efforts, including surveillance of HIV 

infection, Acquired Immunodeficiency 

Syndrome (AIDS), viral hepatitis, other 

STDs, and related behaviors; 

epidemiologic, behavioral, health 

services, and laboratory research on 

HIV, viral hepatitis, and other STDs; 

identification of policy issues related to 

HIV/viral hepatitis/STD professional 

education, patient healthcare delivery, 

and prevention services; agency policies 

about prevention of HIV, viral hepatitis 

and other STDs, treatment, healthcare 

delivery, and research and training; 

strategic issues influencing the ability of 

CDC and HRSA to fulfill their missions 

of providing prevention and treatment 

services; programmatic efforts to 

prevent and treat HIV, viral hepatitis, 

and other STDs; and support to the 

agencies in their development of 

responses to emerging health needs 

related to HIV, viral hepatitis and other 

STDs. 

Nominations are being sought for 

individuals who have expertise and 

qualifications necessary to contribute to 

the accomplishments of the committee’s 

objectives. Nominees will be selected 

based on expertise in the fields of public 

health; epidemiology; laboratory 

practice; immunology; infectious 

diseases; drug abuse; behavioral science; 

health education; healthcare delivery; 

state health programs; clinical care; 

preventive health; medical education; 

health services and clinical research; 

and healthcare financing. The 

Committee shall also include 

representation of persons with HIV and 

other affected populations; state and 

local health and education agencies; 

HIV/viral hepatitis/STD communitybased organizations; and the ethics or 

faith-based community. Federal 

employees will not be considered for 

membership. Members may be invited 

to serve for up to four-year terms. 

Selection of members is based on 

candidates’ qualifications to contribute 

to the accomplishment of CHACHSPT 

objectives. The U.S. Department of 

Health and Human Services policy 

stipulates that committee membership 

be balanced in terms of points of view 

represented, and the committee’s 

function. Appointments shall be made 

without discrimination on the basis of 

age, race, ethnicity, gender, sexual 

orientation, gender identity, HIV status, 

disability, and cultural, religious, or 

socioeconomic status. Nominees must 

be U.S. citizens, and cannot be full-time 

employees of the U.S. Government. 

Current participation on federal 

workgroups or prior experience serving 

on a federal advisory committee does 

not disqualify a candidate; however, 

HHS policy is to avoid excessive 

individual service on advisory 

committees and multiple committee 

memberships. Committee members are 

Special Government Employees (SGEs), 

requiring the filing of financial 

disclosure reports at the beginning and 

annually during their terms. Individuals 

who are selected for appointment will 

be required to provide detailed 

information regarding their financial 

interests and, for example, any work 

they do for the federal government 

through research grants or contracts. 

Disclosure of this information is 

required in order for CDC ethics officials 

to determine whether there is a conflict 

between the SGE’s public duties as 

members of CHACHSPT and their 

private interests, including an 

appearance of a loss of impartiality as 

defined by federal laws and regulations, 

and to identify any required remedial 

action needed to address the potential 

conflict. CDC reviews potential 

candidates for CHACHSPT membership 

when a vacancy arises and provides a 

slate of nominees for consideration to 

the Secretary of HHS for final selection. 

HHS notifies selected candidates of 

their appointment near the start of the 

term in December 1, 2021, or as soon as 

the HHS selection process has been 

completed. Note that the need for 

different expertise varies from year to 

year and a candidate who is not selected 

for an open position may be 

reconsidered for a subsequent open 

position. SGE nominees must be U.S. 

citizens, and cannot be full-time 

employees of the U.S. Government. 

Candidates should submit the following 

items: 

D Current curriculum vitae or resume, 

including complete contact information 

(telephone numbers, mailing address, 

email address). 

D At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. 

(Candidates may submit letters(s) 

from current HHS employees if they 

wish, but at least one letter must be 

submitted by a person not employed by 

an HHS agency (e.g., CDC, NIH, FDA, 

etc.). 

D A biographical sketch of the 

nominee (500 words or fewer). 

D A letter of interest or personal 

statement from the nominee stating how 

their expertise would inform the work 

of CHACHSPT. 

Nominations may be submitted 

directly by the individual seeking 

nomination or by the person/ 

organization recommending the 

candidate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–14686 Filed 7–9–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–21–21GH; Docket No. CDC–2021– 

0065] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled Using Real-time Prescription and 

Insurance Claims Data to Support the 

HIV Care Continuum. This proposed 

collection will collect data to evaluate 


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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 36551 

the efficacy of using administrative 

insurance and prescription claims 

(billing) data to identify and intervene 

upon persons with HIV who fail to fill 

antiretroviral (ARV) prescriptions. 

DATES: CDC must receive written 

comments on or before September 10, 

2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0065 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7118; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Using Real-time Prescription and 

Insurance Claims Data to Support the 

HIV Care Continuum—New—National 

Center for HIV/AIDS, Viral Hepatitis, 

STD and TB Prevention (NCHHSTP), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Use of HIV surveillance data to 

identify out-of-care persons is one 

strategy for identifying and re-engaging 

out-of-care persons, and is called Datato-Care or ‘‘D2C.’’ Data-to-Care uses 

laboratory reports (i.e., CD4 and HIV 

viral load test results) received by a 

health department’s HIV surveillance 

program as markers of HIV care. In the 

current D2C model, there is a delay in 

the identification of out-of-care persons 

due to the time interval between 

recommended monitoring tests (i.e., 

every three to six months) and the 

subsequent reporting of these tests to 

surveillance. 

Insurance and prescription 

administrative claims (billing) data can 

be used to identify persons who fail to 

fill antiretroviral (ARV) prescriptions 

and who are at risk for falling out of 

care. Because most ARVs are prescribed 

as a 30-day supply of medication, 

prescription claims can be used to 

identify persons who are not filling ARV 

prescriptions on a monthly basis. 

Tracking ARV refill data can, therefore, 

be a more real-time indicator of poor 

adherence and can act as a harbinger of 

potential poor retention in care. Using 

real time insurance and prescription 

claims data to identify persons who fail 

to fill ARV prescriptions, and to 

intervene, could have a significant 

impact on ARV therapy adherence, viral 

suppression and potentially on 

retention in care. 

The purpose of the Antiretroviral 

Improvement among Medicaid Enrollees 

(AIMS) study is to develop, implement 

and evaluate a D2C strategy that uses 

Medicaid insurance and prescription 

claims data to identify; (1) persons with 

HIV who have never been prescribed 

ARV therapy, and (2) persons with HIV 

who fail to pick up prescribed ARV 

medications in a timely manner, and to 

target these individuals for adherence 

interventions. 

A validated HIV case identification 

algorithm will be applied to the Virginia 

Medicaid database to identify persons 

with HIV who have either never filled 

an ARV prescription or have not filled 

an ARV prescription within >30 to <90 

days of the expected fill date. 

Deterministic and probabilistic methods 

will be used to link this list to the 

Virginia Department of Health’s (VDH) 

Care Markers database (an extract of the 

VDH HIV surveillance database). 

Individuals that are matched across the 

two databases (indicating that the 

persons are both enrolled in Medicaid 

and confirmed HIV positive) are eligible 

for study participation. Additional 

eligibility criteria include age 19–63 

years and continuous enrollment in 

Virginia Medicaid for the preceding 12 

months. 

Cluster randomization will occur at 

the healthcare provider level and will be 

conducted concurrently with the initial 

potential participant screening. 

Providers will be randomized to either 

the intervention arm or to the usual care 

arm (i.e., no intervention or control 

arm). Study participants are the patients 

of the randomized healthcare providers. 

Participants in the intervention arm will 

be delegated to either a patient-level or 

provider-level intervention, depending 

on need; participants who are >30 to 

<90 days late filling their ARV 

prescription(s) will receive the patientlevel intervention, and participants who 

have never filled an ARV prescription 

will be delegated to the provider-level 

intervention. Participants of the 

provider-level intervention will not 

receive direct intervention. Instead, the 

healthcare providers of these patients 

(‘‘provider participants’’) will receive 

the provider-level intervention. 

Potential participants will be contacted 

by a study Linkage Coordinator to 

explain the study and obtain consent for 

participation. 

The patient-level intervention has two 

phases. Phase I is intended for patients 

who are >30 to <60 days late filling their 

ARV prescription(s). In Phase I, a 

Linkage Coordinator will contact 

participants to discuss the participants’ 

adherence barriers. Once the 

participant’s adherence barriers are 

identified, the participant will be 

referred to appropriate resources to 

assist them in overcoming their 

adherence barrier(s). Phase II is 

intended for patients who were enrolled 


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36552 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices 

in Phase I but who failed to fill their 

ARV prescriptions in the subsequent 30 

days of the Phase I consultation, and for 

participants who are >60 to <90 days 

late at the time the participant was 

determined to be study eligible. In 

Phase II, the Linkage Coordinator will 

lead a similar consultation as in Phase 

I, but will probe for more complex 

adherence barriers (e.g., mental health 

concerns) and referrals will be made 

accordingly. The participant will also be 

offered an evidence-informed mobile 

application (‘‘app’’) which is designed 

to support ART adherence and retention 

in care. 

The provider-level intervention will 

consist of a peer-to-peer clinician 

consultation delivered by clinicians 

from the Virginia Department of 

Health’s Advisory Committee to the 

Virginia Medication Assistance Program 

or by another HIV clinical expert. The 

peer-to-peer clinician consultations will 

involve introduction or reinforcement of 

HIV clinical guidelines for ART 

initiation, strategies to optimize ART 

adherence, and resources for supporting 

adherence for people with HIV. The 

consultation will be tailored to the 

needs of the provider participant. 

All analyses will be conducted at the 

patient level. Persons within the 

intervention arm will be followed 

prospectively for 12 months. At the end 

of the intervention arm follow-up 

period, persons within the usual care 

arm will be followed retrospectively for 

12 months. The primary study outcome 

of HIV viral suppression (HIV RNA 

<200 copies/mL) will be compared 

between study arms. 

CDC requests OMB approval to collect 

standardized information from 500 

AIMS study participants (460 

participants of the patient-level 

intervention and 40 participants of the 

provider-level intervention) and 500 

controls over the three-year project 

period. Secondary data will be 

abstracted from the Virginia Medicaid 

and Virginia Care Markers databases to 

determine study eligibility, to conduct 

the patient- and provider-level 

interventions, and to determine study 

outcomes. During the patient-level 

intervention, data will be collected on 

participants’ adherence barriers; this 

information will be used to refer 

participants to appropriate resources to 

assist their adherence to ART. During 

the provider-level intervention data will 

be collected to inform the peer-to-peer 

clinician consultation. 

CDC requests OMB approval for an 

estimated 687 burden hours annually. 

There are no costs to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Participants ....................................... Verbal consent—participants ........... 460 1 15/60 115 

Provider participants ......................... Verbal consent—provider participants.40 1 15/60 10 

Participants ....................................... Verbal consent—control participants 

(for participants of provider-level 

intervention).

40 1 15/60 10 

Control participants ........................... Verbal consent—control participants 500 1 15/60 125 

PositiveLinks participants .................. PositiveLinks enrollment .................. 100 1 60/60 100 

Participants ....................................... Phase I interview .............................. 460 1 30/60 230 

Participants ....................................... Phase II interview ............................. 100 1 30/60 50 

Advisory Committee to the Virginia 

Medication Assistance Program 

member and other HIV clinical expects.

Clinician consultation ....................... 10 4 30/60 20 

Provider participants ......................... Clinician consultation ....................... 40 1 30/60 20 

Advisory Committee to the Virginia 

Medication Assistance Program 

member and other HIV clinical expects.

Post-consultation questionnaire ....... 10 4 10/60 7 

Total ........................................... ........................................................... ........................ ........................ ........................ 687 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–14752 Filed 7–9–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–21–0530; Docket No. CDC–2021– 

0064] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA) Dose Reconstruction 

Interviews and Forms. This data 

collection permits claimants under 


khammond on DSKJM1Z7X2PROD with NOTICES