60dy Federal Register Notice

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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:

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(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–

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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,

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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.

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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

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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:

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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 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

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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

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