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)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 140 (July 20, 2018)
| Page Range | 34586-34588 | |
| FR Document | 2018-15529 |
[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] ----------------------------------------------------------------------- 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: [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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) (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 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- 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
![34586 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Natural science managers ................ Semi-Structured Interview Guide 10 1 2 20
(Subject Matter Experts).
Postsecondary Teachers .................. Semi-Structured Interview Guide 12 1 2 24
(Grantees).
Industrial production managers ........ Semi-Structured Interview Guide 8 1 2 16
(Research users).
Total ........................................... ........................................................... ........................ ........................ ........................ 60
Jeffrey M. Zirger, ADDRESSES: You may submit comments, 1. Evaluate whether the proposed
Acting Chief, Information Collection Review identified by Docket No. CDC–2018– collection of information is necessary
Office, Office of Scientific Integrity, Office 0058 by any of the following methods: for the proper performance of the
of the Associate Director for Science, Office • Federal eRulemaking Portal: functions of the agency, including
of the Director, Centers for Disease Control Regulations.gov. Follow the instructions whether the information will have
and Prevention. practical utility;
for submitting comments.
[FR Doc. 2018–15527 Filed 7–19–18; 8:45 am] • Mail: Jeffrey M. Zirger, Information 2. Evaluate the accuracy of the
BILLING CODE 4163–18–P Collection Review Office, Centers for agency’s estimate of the burden of the
Disease Control and Prevention, 1600 proposed collection of information,
Clifton Road NE, MS–D74, Atlanta, including the validity of the
DEPARTMENT OF HEALTH AND Georgia 30329. methodology and assumptions used;
HUMAN SERVICES Instructions: All submissions received 3. Enhance the quality, utility, and
must include the agency name and clarity of the information to be
Centers for Disease Control and
Docket Number. CDC will post, without collected; and
Prevention 4. Minimize the burden of the
change, all relevant comments to
[60Day–18–18ANU; Docket No. CDC–2018– Regulations.gov. collection of information on those who
0058] Please note: Submit all comments are to respond, including through the
through the Federal eRulemaking portal use of appropriate automated,
Proposed Data Collection Submitted (regulations.gov) or by U.S. mail to the electronic, mechanical, or other
for Public Comment and address listed above. technological collection techniques or
Recommendations other forms of information technology,
FOR FURTHER INFORMATION CONTACT: To
request more information on the e.g., permitting electronic submissions
AGENCY: Centers for Disease Control and of responses.
Prevention (CDC), Department of Health proposed project or to obtain a copy of
5. Assess information collection costs.
and Human Services (HHS). the information collection plan and
ACTION: Notice with comment period. instruments, contact Jeffrey M. Zirger, Proposed Project
Information Collection Review Office, Communities Organized To Prevent
SUMMARY: The Centers for Disease Centers for Disease Control and Arboviruses: Assessment of Knowledge,
Control and Prevention (CDC), as part of Prevention, 1600 Clifton Road NE, MS– Attitudes, and Vector Control Practices
its continuing effort to reduce public D74, Atlanta, Georgia 30329; phone: and Sero-Prevalence and Incidence of
burden and maximize the utility of 404–639–7570; Email: omb@cdc.gov. Arboviral Infection in Ponce, Puerto
government information, invites the SUPPLEMENTARY INFORMATION: Under the Rico (COPA Study)—NEW—National
general public and other Federal Paperwork Reduction Act of 1995 (PRA) Center for Emerging and Zoonotic
agencies the opportunity to comment on (44 U.S.C. 3501–3520), Federal agencies Infectious Diseases (NCEZID), Centers
a proposed and/or continuing must obtain approval from the Office of for Disease Control and Prevention
information collection, as required by Management and Budget (OMB) for each (CDC).
the Paperwork Reduction Act of 1995. collection of information they conduct
This notice invites comment on a or sponsor. In addition, the PRA also Background and Brief Description
proposed information collection project requires Federal agencies to provide a Recent years have seen the emergence
titled Communities Organized to 60-day notice in the Federal Register of two epidemic arthropod-borne
Prevent Arboviruses: Assessment of concerning each proposed collection of viruses (arboviruses) that are
Knowledge, Attitudes, and Vector information, including each new transmitted by Aedes aegypti
Control Practices and Sero-Prevalence proposed collection, each proposed mosquitoes. Chikungunya virus was
and Incidence of Arboviral Infection in extension of existing collection of introduced into the Caribbean in late
Ponce, Puerto Rico (COPA Study). The information, and each reinstatement of 2013, and caused large epidemics of
purpose of this study is to establish previously approved information fever with severe joint pain throughout
daltland on DSKBBV9HB2PROD with NOTICES
longitudinal follow-up of a community collection before submitting the the Caribbean and Americas in 2014.
cohort and evaluate the impact of vector collection to the OMB for approval. To Zika virus was first detected in the
control interventions in 14 communities comply with this requirement, we are Americas in Brazil in 2014, spread
in southern Puerto Rico. publishing this notice of a proposed throughout the Americas, has since been
DATES: CDC must receive written data collection as described below. associated with devastating birth
comments on or before September 18, The OMB is particularly interested in defects, Guillain-Barre syndrome, and is
2018. comments that will help: the first arbovirus that can also be
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![34588 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (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, including the validity of the prevent unintended pregnancy among
Acting Chief, Information Collection Review methodology and assumptions used; women at risk of Zika virus infection.
Office, Office of Scientific Integrity, Office (c) Enhance the quality, utility, and To this end, an initiative was launched
of the Associate Director for Science, Office clarity of the information to be in April 2016 to train physicians at
of the Director, Centers for Disease Control collected; clinics across Puerto Rico to provide
and Prevention.
(d) Minimize the burden of the patient-centered services to women who
[FR Doc. 2018–15529 Filed 7–19–18; 8:45 am] chose to delay or avoid pregnancy
collection of information on those who
BILLING CODE 4163–18–P
are to respond, including, through the during the Zika virus outbreak.
use of appropriate automated, As part of the public health response
electronic, mechanical, or other to the Zika virus outbreak, CDC seeks to
DEPARTMENT OF HEALTH AND
technological collection techniques or assess approaches to mitigating the
HUMAN SERVICES
other forms of information technology, effects of Zika virus infection and
Centers for Disease Control and e.g., permitting electronic submission of determine which approaches have
Prevention responses; and utility. Previous assessment of the
(e) Assess information collection prevention program indicated high
[30Day–18–18TH] costs. satisfaction of patients with program
To request additional information on services. The specific objectives of this
Agency Forms Undergoing Paperwork data collection are to assess (1)
Reduction Act Review the proposed project or to obtain a copy
of the information collection plan and prevention strategy adherence among
In accordance with the Paperwork instruments, call (404) 639–7570 or patients at approximately 18 months
Reduction Act of 1995, the Centers for send an email to omb@cdc.gov. Direct after receipt of program services; and (2)
Disease Control and Prevention (CDC) written comments and/or suggestions prevention strategy adherence, patient
has submitted the information regarding the items contained in this satisfaction, and unmet need for
collection request titled ‘‘Assessment of notice to the Attention: CDC Desk services among participants at
a Preventive Service Program in the Officer, Office of Management and approximately 30 months after receipt
Context of a Zika Virus Outbreak in Budget, 725 17th Street NW, of program services. The practical utility
Puerto Rico’’ to the Office of Washington, DC 20503 or by fax to (202) of the information to be collected as part
Management and Budget (OMB) for 395–5806. Provide written comments of this project is to assess services
review and approval. CDC previously within 30 days of notice publication. delivered to women in Puerto Rico,
published a ‘‘Proposed Data Collection monitor outcomes of interest, and
Proposed Project determine potential for replication/
Submitted for Public Comment and
Recommendations’’ notice on March 30, Assessment of a Preventive Service adaptation in other jurisdictions
2018 to obtain comments from the Program in the Context of a Zika Virus similarly affected by the Zika virus or
public and affected agencies. CDC Outbreak in Puerto Rico—New— during other emergency responses. For
received one non-substantive comment National Center for Chronic Disease the information collection, CDC plans to
to the previous notice. This notice Prevention and Health Promotion conduct online surveys with 1,920
serves to allow an additional 30 days for (NCCDPHP), Centers for Disease Control patients approximately 18 months after
public and affected agency comments. and Prevention (CDC). receiving program services and 1,760
CDC will accept all comments for this patients approximately 30 months after
Background and Brief Description receiving program services. The number
proposed information collection project.
The Office of Management and Budget Puerto Rico has reported the highest of patients surveyed is based on an
is particularly interested in comments number of Zika virus infections in the initial sample of 3,200 patients invited
that: United States, including infections in to participate, anticipating a 60%
(a) Evaluate whether the proposed pregnant women. Zika virus infection response rate at 18 months and a 55%
collection of information is necessary during pregnancy has been identified as response rate at 30 months.
for the proper performance of the a cause of microcephaly and other Participation in all data collection
functions of the agency, including severe brain abnormalities, and has been activities will be completely voluntary.
whether the information will have linked to other problems such as OMB approval is requested for two
daltland on DSKBBV9HB2PROD with NOTICES
practical utility; miscarriage, stillbirth, defects of the eye, years. Total Annualized Burden Hours
(b) Evaluate the accuracy of the hearing deficits, limb abnormalities, and are estimated to be 259, and there are no
agencies estimate of the burden of the impaired growth. One strategy to costs to respondents other than their
proposed collection of information, prevent these devastating outcomes is to time.
VerDate Sep<11>2014 18:06 Jul 19, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 20JYN1](https://thefederalregister.org/doc/83_FR_34726/page/3.svg)
Document Created: 2018-07-20 01:18:58
Document Modified: 2018-07-20 01:18:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before September 18, 2018. | |
| 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] | |
| FR Citation | 83 FR 34586 |
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