34586 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Natural science managers ................ Semi-Structured Interview Guide 

(Subject Matter Experts).

10 1 2 20 

Postsecondary Teachers .................. Semi-Structured Interview Guide 

(Grantees).

12 1 2 24 

Industrial production managers ........ Semi-Structured Interview Guide 

(Research users).

8 1 2 16 

Total ........................................... ........................................................... ........................ ........................ ........................ 60 

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. 2018–15527 Filed 7–19–18; 8:45 am] 

BILLING CODE 4163–18–P 

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. 

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: 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, 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 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 decisionmaking 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 sociodemographic 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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Ponce residents ............. Household representative questionnaire ............. 2,506 1 10/60 418 

Socio-demographic questionnaire ....................... 2,996 1 15/60 749 

Knowledge, attitudes, and practices individual 

questionnaire.

2,996 1 15/60 749 


daltland on DSKBBV9HB2PROD with NOTICES
34588 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Vector control tools questionnaire ....................... 600 1 25/60 250 

Specimen collection ............................................. 2,996 1 5/60 250 

Total ........................ .............................................................................. ........................ ........................ ........................ 2,416 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–18TH] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Assessment of 

a Preventive Service Program in the 

Context of a Zika Virus Outbreak in 

Puerto Rico’’ to the Office of 

Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on March 30, 

2018 to obtain comments from the 

public and affected agencies. CDC 

received one non-substantive comment 

to the previous notice. This notice 

serves to allow an additional 30 days for 

public and affected agency comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) 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; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) 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 submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Direct 

written comments and/or suggestions 

regarding the items contained in this 

notice to the Attention: CDC Desk 

Officer, Office of Management and 

Budget, 725 17th Street NW, 

Washington, DC 20503 or by fax to (202) 

395–5806. Provide written comments 

within 30 days of notice publication. 

Proposed Project 

Assessment of a Preventive Service 

Program in the Context of a Zika Virus 

Outbreak in Puerto Rico—New— 

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Puerto Rico has reported the highest 

number of Zika virus infections in the 

United States, including infections in 

pregnant women. Zika virus infection 

during pregnancy has been identified as 

a cause of microcephaly and other 

severe brain abnormalities, and has been 

linked to other problems such as 

miscarriage, stillbirth, defects of the eye, 

hearing deficits, limb abnormalities, and 

impaired growth. One strategy to 

prevent these devastating outcomes is to 

prevent unintended pregnancy among 

women at risk of Zika virus infection. 

To this end, an initiative was launched 

in April 2016 to train physicians at 

clinics across Puerto Rico to provide 

patient-centered services to women who 

chose to delay or avoid pregnancy 

during the Zika virus outbreak. 

As part of the public health response 

to the Zika virus outbreak, CDC seeks to 

assess approaches to mitigating the 

effects of Zika virus infection and 

determine which approaches have 

utility. Previous assessment of the 

prevention program indicated high 

satisfaction of patients with program 

services. The specific objectives of this 

data collection are to assess (1) 

prevention strategy adherence among 

patients at approximately 18 months 

after receipt of program services; and (2) 

prevention strategy adherence, patient 

satisfaction, and unmet need for 

services among participants at 

approximately 30 months after receipt 

of program services. The practical utility 

of the information to be collected as part 

of this project is to assess services 

delivered to women in Puerto Rico, 

monitor outcomes of interest, and 

determine potential for replication/ 

adaptation in other jurisdictions 

similarly affected by the Zika virus or 

during other emergency responses. For 

the information collection, CDC plans to 

conduct online surveys with 1,920 

patients approximately 18 months after 

receiving program services and 1,760 

patients approximately 30 months after 

receiving program services. The number 

of patients surveyed is based on an 

initial sample of 3,200 patients invited 

to participate, anticipating a 60% 

response rate at 18 months and a 55% 

response rate at 30 months. 

Participation in all data collection 

activities will be completely voluntary. 

OMB approval is requested for two 

years. Total Annualized Burden Hours 

are estimated to be 259, and there are no 

costs to respondents other than their 

time. 


daltland on DSKBBV9HB2PROD with NOTICES