46852 Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 

time points: Pre (before the training), 

post (after the training), and follow-up 

(4–6 weeks after the training). The 

survey will assess; (1) foundational OSH 

knowledge; (2) OSH attitudes; (3) selfefficacy for OSH; (4) behavioral 

intention to use newly learned OSH 

skills; (5) OSH training perceptions; and 

(6) job safety perceptions. Basic 

demographics and work experience 

information will also be collected from 

field pilot participants, but no sensitive 

or personally identifiable information 

(PII) will be collected by NIOSH. 

Participants in the training group will 

be asked to provide reactions to the 

training during brief post-training 

feedback sessions, and this data will be 

audio recorded. This field pilot will 

follow the CDC COVID–19 interim 

guidance for research activities, 

including in-person activities, in place 

at the time of the activity. This data 

collection will serve as a first step in 

addressing the need for evidence-based, 

foundational OSH training programs for 

the workforce development sector, and 

is aligned with the National 

Occupational Research Agenda (NORA) 

Healthy Work Design and Well-Being, 

Services, and Manufacturing goals 

related to promoting OSH among 

contingent workers. 

As part of the proposed field pilot, 

NIOSH will administer three online 

surveys (pre, post, and follow-up) to 72 

workforce development program 

participants, and the two trained 

PacMtn WDC will conduct post-training 

feedback sessions with the 36 training 

group participants after each training 

session. Each survey will take 

approximately 30 minutes to complete, 

for a total of 90 minutes per participant 

to complete all three surveys. The 

training will take three hours and 20 

minutes to administer, and the post 

training feedback session will take 10 

minutes to complete. 

CDC requests approval for an 

estimated 43 annual burden hours. 

There are no costs to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Workforce development program participant ....... Pre-survey .................... 34 1 30/60 17 

Workforce development program participant ....... Post-survey ................... 29 1 30/60 15 

Workforce development program participant ....... Follow-up Survey .......... 15 1 30/60 8 

Workforce development program participant ....... Post training feedback 

session.

18 1 10/60 3 

Total ............................................................... ....................................... ........................ ........................ ........................ 43 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–17864 Filed 8–19–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–21–21HI; Docket No. CDC–2021– 

0086] 

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 Red Carpet Entry (RCE) Program 

Implementation Project. This study will 

prepare for, implement, and evaluate an 

implementation model of linkage and 

reengagement to HIV care via a toolkit. 

DATES: CDC must receive written 

comments on or before October 19, 

2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0086 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 46853 

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 

Red Carpet Entry (RCE) Program 

Implementation Project—New— 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, and TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

This project involves original, 

implementation research on the Red 

Carpet Entry (RCE) Program to link 

persons with HIV to care within 72 

hours of their diagnosis or their return 

to care after being out of care. Originally 

developed and implemented in 

Washington DC by Whitman Walker 

Health and the DC Department of 

Health’s HIV/AIDS, Hepatitis, STD, and 

TB Administration, Red Carpet Entry 

(RCE) has been shown to successfully 

and rapidly link people who tested HIV 

positive to an HIV care provider. 

Evaluations of RCE found that 70% of 

newly diagnosed people were linked to 

care within 72 hours of their HIV test. 

It was also shown to work for linking 

people who had fallen out of care with 

an HIV provider. An adapted version of 

RCE has also been shown to improve 

health outcomes among adolescents and 

youths in Kenya by quickly linking to 

care. The school-based program 

increased rates of linkage to care from 

56.5% to 97.3% and three-month 

retention in care from 66.0% to 90.0%. 

Based on this, the CDC identified RCE 

as an evidence-informed structural 

intervention and included it in CDC’s 

Compendium of Evidence-based 

Interventions (EBIs) and Best Practices 

for HIV Prevention. 

Having an evidence-informed 

intervention like RCE that can be 

disseminated to the broader HIV health 

care community is important for several 

reasons: (1) Antiretroviral therapy (ART) 

is the best way to manage HIV and 

reduce transmission; (2) ART initiation 

is only possible when someone enters 

health care and then is ultimately 

retained in care; and (3) there are few 

existing evidenced-based structural 

interventions to support this process. 

This bias in the field of HIV 

interventions stems from a focus on 

individual behavior change 

interventions to prevent HIV infection. 

However, as new and effective 

treatments have emerged that reduce the 

likelihood of HIV transmission, HIV 

clinics and other healthcare settings 

have emerged as key contexts for HIV 

prevention by making sure that Persons 

with HIV (PWH) have immediate access 

to ART. Therefore, the field has slowly 

shifted to understanding how providers 

and health systems can be encouraged 

to support PWH to reduce HIV. 

This study will contribute to the field 

by creating tools to support clinics and 

healthcare settings that want to 

implement the RCE Program to link 

PWH to care. A toolkit will be created 

and tested via implementing RCE in two 

clinics. Lessons from the 

implementation of RCE will be used to 

update the toolkit. The final toolkit will 

be disseminated via CDC’s website. 

Furthermore, because the study also 

evaluates the implementation strategies, 

outcomes, and context when RCE is 

being used, the study will be able to 

recommend what is needed to 

implement RCE with fidelity and 

success and incorporate these insights 

into the toolkit. Finally, because 

tracking costs are also a part of the 

evaluation, clinics and health systems 

that are examining potential RCE 

adoption will have material information 

about what is needed to put RCE into 

practice. An understanding of the actual 

costs can provide important justification 

for program planners. 

The results of this study will help 

CDC frame how best to disseminate the 

RCE Program to the broader HIV health 

care community. This is important 

because only federal agencies like CDC 

have the resources and infrastructure to 

broadly disseminate EBIs. Broad 

dissemination and uptake of EBIs like 

RCE can help move population rates of 

HIV suppression which would affect 

population transmission rates. Linkage 

to care, in an era of biomedical HIV 

prevention, is a prevention linchpin. 

CDC requests approval for an estimated 

125 annual burden hours. There are no 

costs to respondents other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

RCE Clients ........................... Screener ............................................................... 180 1 5/60 15 

RCE Implementation Staff .... Staff Survey—Preparation Phase ........................ 8 1 15/60 2 

RCE Implementation Staff .... Staff Survey—Implementation Phase (months 

1,3,5).

8 3 15/60 6 

RCE Implementation Staff .... Staff Survey—Implementation Phase (months 

2,4,6).

8 3 15/60 6 

RCE Implementation Staff .... Staff Interview Guide—Preparation Phase .......... 8 1 1 8 

RCE Implementation Staff .... Staff Interview Guide–Implementation Phase 

(months 1,3,5).

8 3 30/60 12 

RCE Implementation Staff .... Staff Interview Guide–Implementation Phase 

(months 2,4,6).

8 3 30/60 12 

Clinic Leadership ................... Clinic Leadership Interview Guide ....................... 2 1 30/60 1 

Labor Cost Questionnaire .................................... 6 4 1.5 36 

Non-Labor Cost Questionnaire ............................ 2 9 1.5 27 

Total ............................... .............................................................................. ...................... ...................... ...................... 125 


khammond on DSKJM1Z7X2PROD with NOTICES
46854 Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–17863 Filed 8–19–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10280, CMS– 

1557 and CMS–3070G–I] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

October 19, 2021. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10280 Home Health Change of 

Care Notice 

CMS–1557 Survey Report Form for 

Clinical Laboratory Improvement 

Amendments (CLIA) and Supporting 

Regulations 

CMS–3070G–I ICF/IID Survey Report 

Form and Supporting Regulations 

Under the 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. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of the 

Information Collection: Home Health 

Change of Care Notice; Use: The 

purpose of the Home Health Change of 

Care Notice (HHCCN) is to notify 

original Medicare beneficiaries 

receiving home health care benefits of 

plan of care changes. Home health 

agencies (HHAs) are required to provide 

written notice to Original Medicare 

beneficiaries under various 

circumstances involving the reduction 

or termination of items and/or services 

consistent with Home Health Agencies 

Conditions of Participation (COPs). 

The home health COP requirements 

are set forth in § 1891[42 U.S.C. 

1395bbb] of the Social Security Act (the 

Act). The implementing regulations 

under 42 CFR 484.10(c) specify that 

Medicare patients receiving HHA 

services have rights. The patient has the 

right to be informed, in advance about 

the care to be furnished, and of any 

changes in the care to be furnished. The 

HHA must advise the patient in advance 

of the disciplines that will furnish care, 

and the frequency of visits proposed to 

be furnished. The HHA must advise the 

patient in advance of any change in the 

plan of care before the change is made.’’ 

Notification is required for covered 

and non-covered services listed in the 

plan of care (POC). The beneficiary will 

use the information provided to decide 

whether or not to pursue alternative 

options to continue receiving the care 

noted on the HHCCN. Form Number: 

CMS–10280 (OMB control number: 

0938–1196); Frequency: Yearly; Affected 

Public: Private Sector (Business or other 

for-profits, Not-for-Profit Institutions); 

Number of Respondents: 11,157; Total 

Annual Responses: 12,385,108; Total 

Annual Hours: 824,848. (For policy 

questions regarding this collection 

contact Jennifer McCormick at 410–786– 

2852.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations; Use: The form 

is used to report surveyor findings 

during a CLIA survey. For each type of 

survey conducted (i.e., initial 

certification, recertification, validation, 

complaint, addition/deletion of 

specialty/subspecialty, transfusion 

fatality investigation, or revisit 

inspections) the Survey Report Form 

incorporates the requirements specified 

in the CLIA regulations. Form Number: 

CMS–1557 (OMB control number: 

0938–0544); Frequency: Biennially; 

Affected Public: Private sector (Business 

or other for-profit and Not-for-profit 

institutions, State, Local or Tribal 

Governments and Federal Government); 

Number of Respondents: 15,975; Total 


khammond on DSKJM1Z7X2PROD with NOTICES