60d FRN - published

Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–1254; Docket No. CDC–2021–
0121]

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 Communities Organized to
Prevent Arboviruses: Assessment of
Knowledge, Attitudes, and Vector
Control Practices and Sero-Prevalence
and Incidence of Arboviral Infection in
Ponce, Puerto Rico (COPA Study). The
purpose of this study is to measure the
incidence of arboviral infections in 38
communities in southern Puerto Rico.
DATES: CDC must receive written
comments on or before January 21,
2022.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2021–
0121 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 H21–8, 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,

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ADDRESSES:

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Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329; phone:
404–639–7570; 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;
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
Communities Organized to Prevent
Arboviruses: Assessment of Knowledge,
Attitudes, and Vector Control Practices
and Sero-Prevalence and Incidence of
Arboviral Infection in Ponce, Puerto
Rico (COPA Study)—Revision—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The four viruses that cause dengue are
transmitted by Aedes species
mosquitoes and were introduced to the

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Americas over the past several hundred
years where they have since become
endemic. Puerto Rico, a Caribbean
island and U.S. commonwealth, has the
highest burden of dengue virus in the
U.S., and recent years have seen the
emergence of two epidemic arthropodborne viruses (arboviruses) also
transmitted by Aedes mosquitoes.
Chikungunya virus was introduced into
the Caribbean in late 2013 and caused
large epidemics of fever with severe
joint pain throughout the Caribbean and
Americas in 2014. Zika virus, the first
arbovirus that can also be transmitted
through sexual contact, was first
detected in the Americas in 2014 and
has been associated with devastating
birth defects and Guillain-Barre
syndrome. Yellow fever virus has
recently caused large outbreaks in
Brazil, and there is risk of importation
to Puerto Rico and other counties in the
Americas.
The public health response to the
spread of these arboviruses throughout
the tropics, where their mosquito
vectors thrive, has been hampered by a
lack of sustainable and effective
interventions to prevent infection with
any of these arboviruses at the
community level. Moreover, the rapid
speed with which new arboviruses
spread does not often provide the time
needed to plan and implement
community-level interventions to
decrease disease transmission. Although
several candidate vaccines for
chikungunya and Zika viruses are
currently in clinical development, none
are yet available. A dengue vaccine was
recently recommended for children 9–
16 years old with previous dengue
infection and living in dengue-endemic
parts of the United States. However, this
will only benefit a small proportion of
the population at risk for dengue
infection.
The purpose of the Communities
Organized to Prevent Arboviruses
(COPA) project is to measure the
incidence of arboviral infections and
assess suitability, acceptability, and
impact of community-level mosquito
control interventions in 38 communities
in southern Puerto Rico. The study
investigators have prior experience
working in these communities;
however, there is minimal available
information regarding the prevalence or
incidence of infection with tropical
arboviruses, density of Ae. aegypti
mosquitos, or community members’
knowledge, attitudes, and practices

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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Notices

regarding behaviors intended to avoid
mosquitos. Such information will be
needed to inform decision-making
regarding the location, design, and
content of mosquito control
interventions to be implemented, as
well as to evaluate their effectiveness in
reducing the arbovirus burden.
Additionally, the COPA project can act
as a research platform to assess
acceptability of arbovirus vaccines and
other individual level prevention
measures in Puerto Rico and provide
community-level data on emerging
diseases, including novel coronavirus
2019 (COVID–19).
CDC plans to collect demographic
information (e.g., age, sex, duration of
time residing in Puerto Rico), travel
history, and information on recent
illnesses from all participants via
household (and individual)
questionnaires. Parents or guardians
will serve as proxy respondents for
children aged <7 years. The
questionnaires will be administered
after written consent and written or
verbal assent (for minors) from those
present in the household at the time of
the visit. GPS coordinates will also be
collected for each household visited to
later assess for potential clustering of
arboviral infections within
communities. We will ask participants if
they have been ill with arbovirus- or
COVID–19-like illness (i.e., fever, rash,
fever, cough, sore throat, difficulty
breathing, diarrhea, body pain, or loss of
taste/smell in the last week) in the past
week and year. If so, we will collect
details on the symptoms experienced
during their illness. The questionnaires
will be administered to Ponce residents
from the 38 communities in Ponce,
Puerto Rico. Being a resident is defined
by having slept in the house for at least
four of the past seven nights. At the time
of the questionnaire administration, ∼15
mL of blood will be collected to conduct
serological testing of arboviruses for a
sero-survey. If the participant has
COVID–19-like symptoms, an anterior
nasal swab will also be collected.
The questionnaire section will vary
depending on the age of each
participant. The Household
questionnaire will be administered to
one household representative in each
home with one or more COPA
participants. This representative should
be 21 years or older or an emancipated
minor. This information is key to
understand the household composition,
characteristics, and use of chemical

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insecticides and other preventive
practices. If all eligible household
members are unemancipated minors, a
household member over the age of 50
may act as household representative and
complete this section of the survey only.
The Individual questionnaire will be
administered to all participants to
collect individual-level sociodemographic information. This
questionnaire will collect information
on past illnesses and health seeking
behaviors, identify the main healthcare
facilities used in the area, and estimate
costs associated with acute febrile
illness. Questions related to COVID–19
vaccine uptake, illness, and diagnosis
are also included to describe and
estimate the number of previous SARS–
CoV–2 infections and evaluate the
success of ongoing COVID–19
vaccination efforts in these
communities.
The Mobility questionnaire will be
administered to all participants to assess
general individual-level mobility
patterns, including time spent in and
outside of the home each week. We will
ask participants about the location and
characteristics of places where they
spend more than five hours per week to
assess potential arboviral exposures
outside of the home.
The assessment of Knowledge,
Attitudes, and Practices (KAP)
questionnaire will be administered to
participants 14–50 years old to collect
information on knowledge, perceptions
of risk and prevention measures, and
past experience with dengue and
COVID–19. Data will be used to
understand how community members
view arboviral diseases and COVID–19,
and how these perceptions relate to
experience and willingness to adopt
individual and community-level
prevention measures. Questions related
to general perceptions and confidence
in vaccines will be asked to see how
these relate to intentions to vaccinate
against dengue and COVID–19.
A Vector Control Tools questionnaire
will be administered to all household
representatives to evaluate knowledge
and acceptability of several mosquito
control methods. This information will
be shared with local governments and
vector control agencies to inform
selection and implementation of
potential mosquito control interventions
in the region.
An Acute Illness Surveillance (AIS)
project component is being
implemented to better identify and
assess the incidence of arboviral disease

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and COVID–19 among COPA
participants. This additional weekly
activity will use an automated textmessaging system to ask COPA
household representatives and other
household adults who consent to
receive text messages if any COPA
participants in the household have
experienced fever or other COVID-like
symptoms in the past seven days.
Project staff will contact households in
which one or more participants reported
symptoms to schedule an appointment
to collect samples for arbovirus and
SARS–CoV–2 molecular testing and to
administer a AIS questionnaire about
symptoms, exposure and health seeking
behaviors. From previous febrile
surveillance studies, we expect
approximately 40% of household adults
will respond to text messages each week
and 10% of COPA participants will
report acute symptoms and agree to a
sample collection visit each year.
Participants with a positive SARS–
CoV–2 molecular test will be contacted
by phone 2–4 weeks later for a COVID–
19 Case Follow-up questionnaire on
symptoms, health care seeking,
potential exposures, and outcomes of
SARS–CoV–2 infection. We are
expecting that 20% of participant that
report symptoms will have a positive
COVID–19 result and respond to this
follow-up questionnaire.
The central COPA questionnaires
(Household, Individual, KAP, Mobility,
Vector Control) will be repeated among
approximately 3,800 participants every
12 months, up to a period of five years.
The AIS and COVID–19 follow-up
components will be renewed and
modified annually as applicable
according to research and funding
priorities. This project will allow us to
better understand the risk, perceptions,
and burden of arboviral infections and
COVID–19 and evaluate a communitybased approach for vector control in 38
communities in Ponce, Puerto Rico. The
information obtained will inform
decision making regarding the location,
design, content, and evaluation of future
mosquito control interventions
implemented in Puerto Rico. Data on
incidence and perception of COVID–19
disease will also be used to inform local
control programs and fill the current
knowledge gaps.
There is no burden on respondents
other than the time needed to
participate. Estimated annual burden is
4,309 hours.

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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
(in hours)

Form name

Ponce residents from the 38 selected communities 21
years and older or emancipated minor.
Ponce residents from the 38 selected communities 1–50
years old.
Ponce residents from the 38 selected communities 1–50
years old.
Ponce residents from the 38 selected communities 14–
50 years old.
Ponce residents from the 38 selected communities 1–50
years old.
Ponce residents from the 38 selected communities 21
years and older.
Ponce residents from the 38 selected communities 21
years and older.
Ponce residents from the 38 selected communities with
inclusion criteria.
Ponce residents from the 38 selected communities with
inclusion criteria that tested positive for SAR–CoV–2.

Household Representative questionnaire.
Individual questionnaire .....................

2,700

1

10/60

450

3,800

1

20/60

1,267

Specimen Collection ..........................

3,800

1

5/60

317

Knowledge, Attitudes, and Practices
questionnaire.
Mobility ...............................................

3,090

1

15/60

773

3,800

1

10/60

633

Vector Control ....................................

2,500

1

10/60

417

AIS text message ...............................

1,000

52

0.5/60

433

AIS questionnaire ...............................

380

1

8/60

51

COVID–19 case follow-up questionnaire.

75

1

6/60

8

Total ...........................................................................

............................................................

........................

........................

........................

4,309

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–25449 Filed 11–19–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10515]

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,

SUMMARY:

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Number of
respondents

Type of respondents

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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
January 21, 2022.
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: _, 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:

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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–10515 Payment Collections
Operations Contingency Plan
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
Information Collection: Payment
Collections Operations Contingency
Plan; Use: Under sections 1401, 1411,
and 1412 of the Patient Protection and
Affordable Care Act (PPACA) and 45
CFR part 155 subpart D, an Exchange

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