9346 Federal Register / Vol. 86, No. 28 / Friday, February 12, 2021 / Notices 

Background and Brief Description 

The National Center for Health 

Statistics (NCHS) has submitted a sixmonth OMB emergency clearance for a 

Research and Development Survey 

(RANDS) COVID–19 related data 

collection. Since COVID–19 has resulted 

in a public health crisis, this 

information collection requests approval 

to conduct a follow-on survey (Round 3) 

to the previously completed rounds of 

RANDS. Similar to the previous two 

rounds of RANDS completed during 

COVID–19, this information collection 

will use NORC’s AmeriSpeak Panel as 

its sample source. 

The RANDS COVID–19 (Round 3) 

collection will be used for the purpose 

of continuing NCHS’ developmental 

survey methods and will generate data 

that can help explain health-related 

experiences of the United States 

population during this period. The data 

collection includes not only a research 

component, but will also contribute to 

CDC’s ongoing surveillance of the 

COVID–19 pandemic. Given the current 

outbreak and the resulting limitations 

placed on NCHS’ other data collections, 

RANDS will provide NCHS and CDC 

with early estimates of COVID–19- 

related concepts. The questionnaire will 

cover areas such as general health, 

psychological distress, chronic 

conditions, health behaviors, the 

outbreak’s effects on healthcare access, 

loss of work due to illness with COVID– 

19, telemedicine access and use, and 

other health and behavioral aspects 

related to the epidemic. CDC requests 

approval for an estimated 1,734 burden 

hours over the course of the six-month 

approval. There are no costs to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN TABLE

Types of respondents Form name Number of 

participants 

Number of 

responses/ 

participant 

Average hours 

per response 

Response 

burden 

(in hours) 

Individuals or households ................. RANDS–COVID–19 Round 3 .......... 5,200 1 20/60 1,734 

Total ........................................... ........................................................... 5,200 ........................ ........................ 1,734 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–02950 Filed 2–11–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–21–0840 Docket No. CDC–2021– 

0010] 

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 ‘‘NCHHSTP Generic Clearance 

Formative Research and Tool 

Development’’. This information 

collection request is designed to allow 

CDC’s National Center for HIV/AIDS, 

Viral Hepatitis, STD, and TB Prevention 

(NCHHSTP) to conduct formative 

research information collection 

activities used to inform many aspects 

of surveillance, communications, health 

promotion, and research project 

development for NCHHSTP’s four 

priority diseases (HIV/AIDS), sexually 

transmitted diseases/infections (STD/ 

STI), viral hepatitis, tuberculosis 

elimination (TB), and school and 

adolescent health (DASH). 

DATES: CDC must receive written 

comments on or before April 13, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2021– 

0010 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; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

Federal Register / Vol. 86, No. 28 / Friday, February 12, 2021 / Notices 9347 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

5. Assess information collection costs. 

Proposed Project 

NCHHSTP Generic Clearance 

Formative Research and Tool 

Development (OMB Control No. 0920– 

0840, Exp. 10/31/2021)—Extension— 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention, National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP) requests 

approval for an extension and a three 

year approval for the previously 

approved Generic Clearance, 

‘‘Formative Research and Tool 

Development’’. This information 

collection request is designed to allow 

NCHHSTP to conduct formative 

research information collection 

activities used to inform many aspects 

of surveillance, communications, health 

promotion, and research project 

development for NCHHSTP’s four 

priority diseases (HIV/AIDS, sexually 

transmitted diseases/infections (STD/ 

STI), viral hepatitis, tuberculosis 

elimination and the Division of School 

and Adolescent Heath (DASH). 

Formative research is the basis for 

developing effective strategies including 

communication channels, for 

influencing behavior change. It helps 

researchers identify and understand the 

characteristics—interests, behaviors and 

needs—of target populations that 

influence their decisions and actions. 

Formative research is integral in 

developing programs as well as 

improving existing and ongoing 

programs. Formative research also looks 

at the community in which a public 

health intervention is being or will be 

implemented and helps the project staff 

understand the interests, attributes and 

needs of different populations and 

persons in that community. Formative 

research is research that occurs before a 

program is designed and implemented, 

or while a program is being conducted. 

NCHHSTP formative research is 

necessary for developing new programs 

or adapting programs that deal with the 

complexity of behaviors, social context, 

cultural identities, and health care that 

underlie the epidemiology of HIV/AIDS, 

viral hepatitis, STDs, and TB in the 

U.S., as well as for school and 

adolescent health. 

CDC conducts formative research to 

develop public-sensitive 

communication messages and user 

friendly tools prior to developing or 

recommending interventions, or care. 

Sometimes these studies are entirely 

behavioral but most often they are 

cycles of interviews and focus groups 

designed to inform the development of 

a product. Products from these 

formative research studies will be used 

for prevention of HIV/AIDS, Sexually 

Transmitted Infections (STI), viral 

Hepatitis, and Tuberculosis. Findings 

from these studies may also be 

presented as evidence to diseasespecific National Advisory Committees, 

to support revisions to recommended 

prevention and intervention methods, as 

well as new recommendations. 

Much of CDC’s health communication 

takes place within campaigns that have 

lengthy planning periods—timeframes 

that accommodate the standard Federal 

process for approving data collections. 

Short term qualitative interviewing and 

cognitive research techniques have 

previously proven invaluable in the 

development of scientifically valid and 

population-appropriate methods, 

interventions, and instruments. 

This request includes studies 

investigating the utility and 

acceptability of proposed sampling and 

recruitment methods, intervention 

contents and delivery, questionnaire 

domains, individual questions, and 

interactions with project staff or 

electronic data collection equipment. 

These activities will also provide 

information about how respondents 

answer questions and ways in which 

question response bias and error can be 

reduced. 

This request also includes collection 

of information from public health 

programs to assess needs related to 

initiation of a new program activity or 

expansion or changes in scope or 

implementation of existing program 

activities to adapt them to current 

needs. The information collected will be 

used to advise programs and provide 

capacity-building assistance tailored to 

identified needs. Overall, these 

development activities are intended to 

provide information that will increase 

the success of the surveillance or 

research projects through increasing 

response rates and decreasing response 

error, thereby decreasing future data 

collection burden to the public. The 

studies that will be covered under this 

request will include one or more of the 

following investigational modalities: (1) 

Structured and qualitative interviewing 

for surveillance, research, interventions 

and material development, (2) cognitive 

interviewing for development of specific 

data collection instruments, (3) 

methodological research (4) usability 

testing of technology-based instruments 

and materials, (5) field testing of new 

methodologies and materials, (6) 

investigation of mental models for 

health decision-making, to inform 

health communication messages, and (7) 

organizational needs assessments to 

support development of capacity. 

Respondents who will participate in 

individual and group interviews 

(qualitative, cognitive, and computer 

assisted development activities) are 

selected purposively from those who 

respond to recruitment advertisements. 

In addition to utilizing advertisements 

for recruitment, respondents who will 

participate in research on survey 

methods may be selected purposively or 

systematically from within an ongoing 

surveillance or research project. 

Participation by respondents is 

voluntary. There is no cost to 

participants other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average hours 

per response 

Total response 

burden 

(hours) 

General public and health care providers.Screener ........................................... 81,200 1 10/60 13,533 

General public and health care providers.Consent Forms ................................. 40,600 1 5/60 3,383 

General public and health care providers.Individual Interview ........................... 6,600 1 1 6,600 

General public and health care providers.Focus Group Interview ..................... 4,000 1 2 8,000 

9348 Federal Register / Vol. 86, No. 28 / Friday, February 12, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average hours 

per response 

Total response 

burden 

(hours) 

General public and health care providers.Survey of Individual .......................... 30,000 1 30/60 15,000 

Total ........................................... ........................................................... ........................ ........................ ........................ 46,516 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–02952 Filed 2–11–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–10518 and 

CMS–10340] 

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 

April 13, 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 llll, 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 

https://www.cms.gov/Regulations-andGuidance/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–10518 Application for 

Participation in the Intravenous 

Immune Globulin (IVIG) 

Demonstration 

CMS–10340 Collection of Encounter 

Data from MA Organizations 

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 without change of a 

currently approved collection; Title of 

Information Collection: Application for 

Participation in the Intravenous 

Immune Globulin (IVIG) Demonstration; 

Use: Traditional fee-for-service (FFS) 

Medicare covers some or all 

components of home infusion services 

depending on the circumstances. By 

special statutory provision, Medicare 

Part B covers intravenous immune 

globulin (IVIG) for persons with primary 

immune deficiency disease (PIDD) who 

wish to receive the drug at home. 

However, Medicare does not separately 

pay for any services or supplies to 

administer it if the person is not 

homebound and otherwise receiving 

services under a Medicare Home Health 

episode of care. As a result, many 

beneficiaries have chosen to receive the 

drug at their doctor’s office or in an 

outpatient hospital setting. 

The Medicare IVIG Demonstration 

application requests basic demographic 

information necessary to determine 

eligibility for participation in the 

demonstration. This information is used 

by CMS’ implementation support 

contractor to determine eligibility for 

the demonstration and to set up a 

demonstration eligibility record that is 

used by the Medicare claims system 

when processing claims for 

demonstration services. 

The application also includes some 

questions about how and where the 

beneficiary is currently receiving 

immunoglobulin and related services. 

This data is being used by the 

evaluation contractor to conduct its 

evaluation and to better understand