83 FR 34586 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 140 (July 20, 2018)

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 establish longitudinal follow-up of a community cohort and evaluate the impact of vector control interventions in 14 communities in southern Puerto Rico.

[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34586-34588]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18ANU; Docket No. CDC-2018-0058]


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.

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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 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 
establish longitudinal follow-up of a community cohort and evaluate the 
impact of vector control interventions in 14 communities in southern 
Puerto Rico.

DATES: CDC must receive written comments on or before September 18, 
2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0058 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: 404-639-7570; 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; and
    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.
    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)--NEW--National Center for Emerging and Zoonotic Infectious 
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Recent years have seen the emergence of two epidemic arthropod-
borne viruses (arboviruses) that are transmitted by Aedes aegypti 
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 was first 
detected in the Americas in Brazil in 2014, spread throughout the 
Americas, has since been associated with devastating birth defects, 
Guillain-Barre syndrome, and is the first arbovirus that can also be

[[Page 34587]]

transmitted through sexual contact. In addition, the four viruses that 
cause dengue were introduced to the Americas over the past several 
hundred years and have since become endemic, and yellow fever virus has 
recently caused large outbreaks in Brazil and there is risk of 
importation to other counties in the Americas.
    In all of these cases, 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. Additionally, 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 are currently in clinical development, none are yet available. A 
dengue vaccine has been licensed in several countries, but initial 
analyses have suggested that decades will be needed before it results 
in reduction in transmission of dengue virus. In recent years, 
community based strategies for vector control have been studied and 
implemented in different countries as an alternative to vertical 
strategies (e.g. insecticide spraying delivered by government 
agencies). A new intervention has recently been demonstrated to reduce 
the rates of infection with common tropical arboviruses transmitted by 
Ae. aegypti mosquitos (i.e., dengue, chikungunya, and Zika viruses). 
The Camino Verde approach utilizes community mobilization to motivate 
clean-up campaigns to reduce rates of dengue virus infections in 
Nicaragua and Mexico. However, the intervention occurred in small 
communities, and has not been evaluated in an urban setting. There is 
therefore, a need to determine the effectiveness of such types of 
interventions in relatively large, urban communities.
    Research suggests that vector control programs that have 
substantial community participation can have significant and lasting 
impacts on vector density, and are more cost-effective than vertically 
structured programs. In addition, these types of programs have been 
reported to readily integrate with other health or development 
programs, promote an enduring sense of pride in the home and community, 
and make use of politically viable vector control strategies.
    The purpose of this study is to establish longitudinal follow-up of 
a community cohort and evaluate the impact of vector control 
interventions in 14 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 regarding behaviors intended to avoid mosquitos. Such 
information will be needed to inform decision-making regarding the 
location, design, and content of interventions to be implemented and 
evaluated to reduce the burden of these pathogens.
    The questionnaire section will vary depending on age and day of 
birth of each participant. A questionnaire with general household 
questions will be administered to one household representative in each 
home with one or more participants. This representative should be 21 
years or older or an emancipated minor. 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. A questionnaire on socio-demographic information will be 
administered to all participants. The assessment of knowledge, 
attitudes, and practices questionnaire will be administered to all 
participants seven years and older with questions adapted for ages: 7-
11 (younger child), 12-13 (older child), 14-50 (adult). A vector 
control tools questionnaire will be administered to all participants 21 
years or older born on an odd numbered day of the month. The 
questionnaire will be administered after written consent and verbal 
assent (when appropriate) from those present in the household at the 
time of the visit. The knowledge, attitudes, and practices 
questionnaire will be focused on vector control, healthcare-seeking 
behavior, and disease occurrence. We will 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 
verbal assent (when appropriate) 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-like illness (i.e., fever, rash, joint pain, 
and conjunctivitis) in the past year. If so, we will collect details on 
the symptoms experienced during their illness. The questionnaires will 
be administered to all randomly selected residents of the 14 
communities in Ponce. At the time of the questionnaire administration, 
~15 mL of blood will be collected to conduct serological testing of 
arboviruses for a sero-survey. The sero-survey and socio-demographic 
questionnaire will be repeated every 12 months after the initial 
assessment, up to a period of five years. OMB clearance will be 
extended after three years. This project will allow the evaluation of a 
community based approach for vector control strategies in Ponce, Puerto 
Rico. The information obtained will inform decision making regarding 
the location, design, and content of future interventions to be 
implemented and evaluated to reduce the burden of arboviral disease in 
Puerto Rico. Incidence and prevalence of arboviral disease will be 
estimated to guide control programs development and fill the current 
knowledge gaps.
    There is no burden on respondents other than the time needed to 
participate. Estimated annual burden is 2,416 hours. Authorizing 
legislation comes from Section 301 of the Public Health Service Act.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
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Ponce residents................................  Household representative questionnaire.           2,506               1           10/60             418
                                                 Socio-demographic questionnaire........           2,996               1           15/60             749
                                                 Knowledge, attitudes, and practices               2,996               1           15/60             749
                                                  individual questionnaire.

[[Page 34588]]

 
                                                 Vector control tools questionnaire.....             600               1           25/60             250
                                                 Specimen collection....................           2,996               1            5/60             250
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           2,416
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-15529 Filed 7-19-18; 8:45 am]
 BILLING CODE 4163-18-P