Proposed Data Collection Submitted for Public Comment and Recommendations, 9346-9348 [2021-02952]

Download as PDF 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 RANDS will provide NCHS and CDC with early estimates of COVID–19related 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. 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, ESTIMATED ANNUALIZED BURDEN TABLE Number of participants Number of responses/ participant Average hours per response Response burden (in hours) Types of respondents Form name 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 Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: 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 SUMMARY: VerDate Sep<11>2014 17:27 Feb 11, 2021 Jkt 253001 (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– PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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, E:\FR\FM\12FEN1.SGM 12FEN1 9347 Federal Register / Vol. 86, No. 28 / Friday, February 12, 2021 / Notices 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 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. 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 ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent General public viders. General public viders. General public viders. General public viders. VerDate Sep<11>2014 Number of respondents Form name Number of responses per respondent Average hours per response Total response burden (hours) and health care pro- Screener ........................................... 81,200 1 10/60 13,533 and health care pro- Consent Forms ................................. 40,600 1 5/60 3,383 and health care pro- Individual Interview ........................... 6,600 1 1 6,600 and health care pro- Focus Group Interview ..................... 4,000 1 2 8,000 17:27 Feb 11, 2021 Jkt 253001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1 9348 Federal Register / Vol. 86, No. 28 / Friday, February 12, 2021 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Form name General public and health care providers. Survey of Individual .......................... Total ........................................... ........................................................... 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 Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 SUMMARY: VerDate Sep<11>2014 17:27 Feb 11, 2021 Jkt 253001 Number of responses per respondent Average hours per response Total response burden (hours) 30,000 1 30/60 15,000 ........................ ........................ ........................ 46,516 Number of respondents Type of respondent recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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 E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Pages 9346-9348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02952]


-----------------------------------------------------------------------

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: 
[email protected].

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,

[[Page 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 disease-specific 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
      Type of respondent            Form name        Number of     responses per   Average hours  Total response
                                                    respondents     respondent     per response   burden (hours)
----------------------------------------------------------------------------------------------------------------
General public and health care  Screener........          81,200               1           10/60          13,533
 providers.
General public and health care  Consent Forms...          40,600               1            5/60           3,383
 providers.
General public and health care  Individual                 6,600               1               1           6,600
 providers.                      Interview.
General public and health care  Focus Group                4,000               1               2           8,000
 providers.                      Interview.

[[Page 9348]]

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


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