Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41265 

releases and determine their health 

statuses; 

2. Identify needs (i.e., medical and 

basic) of those exposed during the 

releases to aid in planning interventions 

in the community; 

3. Assess the impact of the incidents 

on health services use and share lessons 

learned for use in hospital, local, and 

state planning for chemical incidents; 

and 

4. Identify cohorts may be followed 

and assessed for persistent health effects 

resulting from acute releases. 

Because each chemical incident is 

different, it is not possible to predict in 

advance exactly what type of and how 

many respondents will be consented 

and interviewed too effectively evaluate 

the incident. Respondents typically 

include, but are not limited to 

emergency responders such as police, 

fire, hazardous material technicians, 

emergency medical services, and 

personnel at hospitals where patients 

from the incident were treated. 

Incidents may occur at businesses or in 

the community setting; therefore, 

respondents may also include business 

owners, managers, workers, customers, 

community residents, pet owners, and 

those passing through the affected area. 

The multidisciplinary ACE team 

consisting of staff from ATSDR, the 

Centers for Disease Control and 

Prevention (CDC), and the requesting 

agencies that will be collecting data. 

ATSDR has developed a quickly tailored 

series of draft survey forms used in the 

field to collect data that will meet the 

goals of the investigation. ATSDR 

collections will be administered based 

on time permitted and urgency. For 

example, it is preferable to administer 

the general survey to as many 

respondents as possible. However, if 

there are time constraints, the shorter 

household survey or the ACE Short 

Form may be administered instead. The 

individual surveys collect information 

about exposure, acute health effects, 

health services use, medical history, 

needs resulting from the incident, 

communication during the release, 

health impact on children and pets, and 

demographic data. Hospital personnel 

are asked about the surge, response and 

communication, decontamination, and 

lessons learned. 

Depending on the situation, data 

collected by face-to-face interviews, 

telephone interviews, written surveys, 

mailed surveys, or on-line surveys can 

be consider collected. Medical and 

veterinary charts may also be consider 

for review. In rare situations, an 

investigation might involve collection of 

clinical specimens. 

ATSDR anticipates up to four ACE 

investigations per year. The number of 

participants has ranged from 30–715, 

averaging about 300 per year. Therefore, 

the total annualized estimated burden 

will be 591 hours per year. Participation 

in ACE investigations is voluntary and 

there are no anticipated costs to 

respondents other than their time. 

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) 

Residents, first responders, business 

owners, employees, customers.

General Survey ................................

ACE Short Form ...............................

800 

50 

1 

1 

30/60 

7/60 

400 

6 

Residents .......................................... Household Survey ............................ 120 1 15/60 30 

Hospital staff ..................................... Hospital Survey ................................ 40 1 30/60 20 

Staff from state, local, or tribal health 

agencies.

Medical Chart Abstraction Form ...... 250 1 30/60 125 

Veterinary Chart Abstraction Form .. 30 1 20/60 10 

Total ........................................... ........................................................... ........................ ........................ ........................ 591 

Leroy A. Richardson, 

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. 2017–18404 Filed 8–29–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–17–1190; Docket No. CDC–2017– 

0073] 

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 efforts to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on the proposed project titled 

‘‘ZEN Colombia Study: Zika in Pregnant 

Women and Children in Colombia.’’ 

DATES: Written comments must be 

received on or before October 30, 2017. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2017– 

0073 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Leroy A. Richardson, 

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. All relevant comments 

received will be posted without change 

to Regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

Regulations.gov. 

Please note: All public comment 

should be submitted 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 Leroy A. 

Richardson, Information Collection 

mstockstill on DSK30JT082PROD with NOTICES

41266 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 

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 OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

Proposed Project 

ZEN Colombia Study: Zika in 

Pregnant Women and Children in 

Colombia, (OMB No. 0920–1190, 

expires 07/31/2019)—Revision— 

Pregnancy and Birth Defects Task Force, 

National Center for Birth Defects and 

Developmental Disabilities, Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Zika virus (ZIKV) infection is a 

mosquito-borne flavivirus transmitted 

by Aedes species mosquitoes, and 

through sexual and mother-to-child 

transmission. Laboratory-acquired 

infections have also been reported. 

Health officials observed sporadic 

evidence of human ZIKV infection in 

Africa and Asia prior to 2007, when an 

outbreak of ZIKV caused an estimated 

5,000 infections in the State of Yap, 

Federated States of Micronesia. Since 

then, health officials have found 

evidence of ZIKV in 65 countries and 

territories, mostly in Central and South 

America. 

Common symptoms of ZIKV in 

humans include rash, fever, arthralgia, 

and nonpurulent conjunctivitis. The 

illness is usually mild and self-limited, 

with symptoms lasting for several days 

to a week; however, based on previous 

outbreaks, some infections are 

asymptomatic. The prevalence of 

asymptomatic infection in the current 

Central and South American epidemic 

is unknown. 

Although the clinical presentation of 

ZIKV infection is typically mild, ZIKV 

infection in pregnancy can cause 

microcephaly and related brain 

abnormalities when fetuses are exposed 

in utero. Other adverse pregnancy 

outcomes related to ZIKV infection 

remain under study, and include 

pregnancy loss, other major birth 

defects, arthrogryposis, eye 

abnormalities, and neurologic 

abnormalities. 

As the spectrum of adverse health 

outcomes potentially related to ZIKV 

infection continues to grow, large gaps 

remain in our understanding of ZIKV 

infection in pregnancy. These include 

the full spectrum of adverse health 

outcomes in pregnant women, fetuses, 

and infants associated with ZIKV 

infection; the relative contributions of 

sexual transmission and mosquito-borne 

transmission to occurrence of infections 

in pregnancy; and variability in the risk 

of adverse fetal outcomes by gestational 

week of maternal infection or symptoms 

of infection. There is an urgency to fill 

these large gaps in our understanding 

given the rapidity of the epidemic’s 

spread and the severe health outcomes 

associated with ZIKV to date. 

Colombia’s Instituto Nacional de 

Salud (INS) began surveillance for ZIKV 

in 2015, reporting the first 

autochthonous transmission in October 

2015 in the north of the country. As of 

December 2016, Colombia has reported 

over 106,000-suspected ZIKV cases, 

with over 19,000 of them among 

pregnant women. With a causal link 

established between ZIKV infection in 

pregnancy and microcephaly, there is an 

urgent need to understand: How to 

prevent ZIKV transmission; the full 

spectrum of adverse maternal, fetal, and 

infant health outcomes associated with 

ZIKV infection; and risk factors for 

occurrence of these outcomes. To 

answer these questions, INS and the 

CDC will follow 5,000 women enrolled 

in the first trimester of pregnancy, their 

male partners, and their infants, in 

various cities in Colombia where ZIKV 

transmission is currently ongoing. 

The primary study objectives are to: 

(1) Describe the sociodemographic and 

clinical characteristics of the study 

population; (2) Identify risk factors for 

ZIKV infection in pregnant women and 

their infants. These include behaviors 

such as use of mosquito-bite prevention 

measures or condoms, and factors 

associated with maternal-to-child 

transmission; (3) Assess the risk for 

adverse maternal, fetal, and infant 

outcomes associated with ZIKV 

infection; (4) Assess modifiers of the 

risk for adverse outcomes among 

pregnant women and their infants 

following ZIKV infection. This includes 

investigating associations with 

gestational age at infection, presence of 

ZIKV symptoms, extended viremia, 

mode of transmission, prior infections 

or immunizations, and co-infections. 

The project aims to enroll 

approximately 5,000 women, 1,250 male 

partners, 4,500 newborns, and a subset 

of 1000 infants/children. Pregnant 

women will be recruited in the first 

trimester of pregnancy for study 

enrollment, followed by assessments 

during pregnancy (every other week 

until 32 weeks gestation and monthly 

thereafter), and within 10 days 

postpartum. At all visits, participants 

will complete visit-specific 

questionnaires. In addition to the 

questionnaires, at all pregnancy and 

delivery visits, participants will receive 

Colombian national recommended 

clinical care and provide samples for 

laboratory testing. 

Researchers will recruit male partners 

around the time of the pregnant 

partners’ study enrollment, followed by 

monthly visits until his pregnant 

partner reaches the third trimester 

(approximately 27 weeks gestation). If 

the male partner contracts ZIKV during 

this time, visits will occur every other 

week until the partner has two negative 

consecutive tests for ZIKV or the 

pregnancy ends. At all study visits, male 

partners will complete visit-specific 

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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41267 

questionnaires and provide samples for 

laboratory testing. 

Researchers will follow all studyparticipating mothers’ newborns every 

other week from birth to 6 months of 

age. At all visits, infants will receive 

national recommended clinical care (at 

birth and follow-up visits at 1, 2, and 6 

months), provide samples for laboratory 

testing, and mothers will complete 

study-specific questionnaires about 

infant ZIKV symptoms and 

developmental milestones. During 

follow-up, infants will also have cranial 

ultrasounds, their head circumference 

measured, and hearing and vision tests. 

For mothers and their infants, 

researchers will abstract relevant 

clinical care information from medical 

records. 

The revised information collection 

package includes the following changes. 

During the data collection period, 

researchers will follow a subset of 300 

infants until 2-years of age. These 

infants will have answer questionnaires 

at 6, 12, 18, and 24 months, as well as 

have other clinical assessments 

performed to exam developmental 

delays. 

Researchers will use the study results 

use to guide recommendations made by 

both INS and CDC to prevent ZIKV 

infection; to improve counseling of 

patients about risks to themselves, their 

pregnancies, their partners, and their 

infants; and to help agencies prepare to 

provide services to affected children 

and families. Participation in this study 

is voluntary and there are no costs to 

participants other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Pregnant women ................... Pregnant women eligibility questionnaire ....

Pregnant women enrollment questionnaire

Adult symptoms questionnaire .....................

Pregnant women follow-up questionnaire ....

Infant symptoms questionnaire ....................

3,125 

2,500 

2,500 

2,500 

2,250 

1 

1 

15 

8 

14 

5/60 

35/60 

10/60 

15/60 

10/60 

260 

1,458 

6,250 

5,000 

5,250 

Ages and Stages Questionnaire: 2, 4, 6 

Month.

Ages and Stages Questionnaire: 12, 18, 24 

Month.

Center for Epidemiologic Studies Depression—10.

2,250 

300 

300 

2 

3 

3 

15/60 

15/60 

5/60 

1,125 

225 

75 

Male partners ........................ Male partner eligibility questionnaire ...........

Male enrollment questionnaire .....................

Adult symptoms questionnaire .....................

2,500 

625 

625 

1 

1 

7 

5/60 

25/60 

10/60 

208 

260 

729 

Total ............................... ....................................................................... ........................ ........................ ........................ 20,840 

Leroy A. Richardson, 

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. 2017–18405 Filed 8–29–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–17–0004] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (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. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National Disease Surveillance 

Program II. Disease Summaries (OMB 

Control Number 0920–0004, Expires 

10/31/2017)—Revision—National 

Center for Immunization and 

Respiratory Diseases, Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

CDC requests a three-year approval for 

the proposed revision of the ‘‘National 

Disease Surveillance Program II. Disease 

Summaries’’ information collection 

project. 

As with the previous approval, these 

data are essential for measuring trends 

in diseases, evaluating the effectiveness 

of current preventive strategies, and 

determining the need to modify current 

preventive measures. 

mstockstill on DSK30JT082PROD with NOTICES