Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51839 

populations, and to prevent the 

introduction, transmission, or spread of 

communicable diseases within the 

United States. Insights gained from this 

information collection will assist in 

pandemic preparedness planning and 

implementation of CDC Pre-Pandemic 

Guidance on the use of school related 

measures, including school closures, to 

slow transmission during an influenza 

pandemic. 

School closures were considered an 

important measure during the earliest 

stage of the 2009 H1N1 pandemic, 

because a pandemic vaccine was not 

available until October (six months 

later), and sufficient stocks to immunize 

all school-age children were not 

available until December. However, 

retrospective review of the U.S. 

government response to the pandemic 

identified a limited evidence-base 

regarding the effectiveness, 

acceptability, and feasibility of various 

school related measures during mild or 

moderately severe pandemics. Guidance 

updates will require an evidence-based 

rationale for determining the 

appropriate triggers, timing, and 

duration of school related measures, 

including school closures, during a 

pandemic. 

CDC staff proposes that the 

information collection for this project 

will target adult and child populations 

in a school district in Wisconsin. CDC 

will collect reports of individual student 

symptoms, vaccination status, recent 

travel, recent exposure to people with 

influenza symptoms, and duration of 

illness. In accordance with the revised 

proposal, CDC will also collect reports 

on household composition, and 

influenza vaccination status; symptoms 

and severity of illness; related 

healthcare visits; and missed work or 

school of the participating students’ 

household members. This information 

accomplished through telephone and inperson interviews. 

CDC will use findings obtained from 

this information to inform and update 

CDC’s Pre-pandemic Guidance on the 

implementation of school related 

measures to prevent the spread of 

influenza, especially school closures. 

Both state and local health departments 

in the United States use this guidance 

as an important planning and reference 

tool. 

CDC has enrolled in the study 651 

students absent from school due to ILI 

since gaining OMB approval in 

December 2014, 651 students absent 

from school due to ILI. Of them, 58% 

were positive for at least one respiratory 

pathogen included in the PCR panel that 

tests for the presence of 17 common 

respiratory viruses, and 27% of the 

students were found to be positive for 

influenza. It was demonstrated that 

absenteeism due to ILI in school 

children was highly correlated with 

PCR-confirmed influenza in enrolled 

school children (r = 0.73; P < 0.001) and 

with medically-attended influenza in 

the surrounding community (r = 0.72; P 

< 0.001) suggesting that ILI-specific 

school absenteeism can be considered a 

useful tool for predicting influenza 

outbreaks in the surrounding 

community. However, researchers 

require more observations during 

influenza seasons caused by other 

influenza strains to make these findings 

more robust. 

This revision adds a household 

transmission component to the ongoing 

approved information collection. In 

addition to collecting data and 

biospecimens from students who were 

absent from school because of the ILI, 

information and biospecimens will also 

be collected from household members of 

these students. This revision aims to 

enhance current knowledge and 

understanding of introduction of 

influenza infection to households that 

have school-age children as well as 

within-household transmission. 

There are no costs to the respondents 

other than their time. The total 

estimated annual burden hours are 419. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Parents of children/adolescents or adult students (≥18 yo) attending schools.Screening Form ..............................................

Acute Respiratory Infection and Influenza 

Surveillance Form.

345 

300 

1 

1 

5/60 

15/60 

Household Study Form .................................. 300 1 5/60 

Student ............................................................ Biospecimen collection ................................... 300 2 5/60 

Household members ....................................... Household Study Form .................................. 720 2 10/60 

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. 2017–24315 Filed 11–7–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–17AZX] 

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 Zika Puerto 

Rico Study: Zika Virus RNA Persistence 

in Pregnant Women and Congenitally 

Exposed Infants 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 April 19, 2017 to obtain 

comments from the public and affected 

agencies. CDC did not receive comments 

related 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 


ethrower on DSK3G9T082PROD with NOTICES
51840 Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 

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 

Zika Puerto Rico Study: Zika Virus 

RNA Persistence in Pregnant Women 

and Congenitally Exposed Infants in 

Puerto Rico—New—National Center of 

Birth Defects and Developmental 

Disabilities, Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Puerto Rico Department of Health 

(PRDH) reported the first case of 

autochthonous transmission of Zika 

virus (ZIKV) in December 2015. As of 

December 16, 2016, Puerto Rico 

reported 35,648 ZIKV cases, more than 

any other location in the U.S., and 

health officials expect the number of 

cases to continue to rise. Among the 

cases, 2,864 have been among pregnant 

women, and the PRDH announced the 

first case of microcephaly in a fetus with 

confirmed ZIKV infection on May 13, 

2016. Currently, testing for ZIKV 

infection can be done by either using 

rRT–PCR to detect the presence of ZIKV 

RNA or by serologic testing to detect 

IgM and neutralizing antibodies. rRT– 

PCR testing is the preferred and 

suggested method for diagnosing ZIKV 

infection because it provides a 

definitive diagnosis and is not subject to 

the limitations (e.g., cross-reactivity) 

associated with serology testing. 

However because level of viremia is 

generally low and RNA concentrations 

decline over time, ZIKV rRT–PCR has 

generally only been considered for a 

short testing window (2 weeks). 

Currently, the CDC and the PRDH 

recommend ZIKV testing of all pregnant 

women living in areas with active ZIKV 

transmission, such as Puerto Rico. 

Symptomatic pregnant women should 

have serum and urine tested for the 

presence of ZIKV RNA by rRT–PCR 

within two weeks of symptom onset. 

Symptomatic pregnant women tested 

more than two weeks after symptom 

onset and symptomatic women with 

negative rRT–PCR test results should 

have serologic testing. CDC recommends 

serologic testing of asymptomatic 

pregnant women at the initiation of 

prenatal care and again during their 

second and third trimesters as a part of 

routine care; CDC recommends serum 

and urine rRT–PCR testing after a 

positive or equivocal serological test 

result to identify persistent RNA and to 

provide a definitive diagnosis. For 

infants, CDC currently recommends 

ZIKV testing within two days of life for 

infants born to women with laboratory 

evidence of possible ZIKV and for 

infants who have abnormal clinical or 

neuroimaging findings suggestive of 

congenital ZIKV syndrome, regardless of 

maternal ZIKV test results. 

Limited data suggest that ZIKV RNA 

might be detectable for a much longer 

period in whole blood than in serum or 

urine; however, researchers have 

primarily seen these results in nonpregnant adults. While ZIKV RNA 

typically only persists in serum for 3– 

7 days and is thought to clear by 10 

days, animal data suggest that 

pregnancy may be associated with 

prolonged detection of ZIKV RNA. An 

ongoing study of pregnant Rhesus 

macaques found ZIKV RNA in plasma 

up to 36 and 71 days post first trimester 

infection, and up to 9 and 36 days after 

third trimester infection. Preliminary 

results from a first trimester-infected 

macaque with detectable virus for 71 

days indicate that the fetus had no 

clinical signs of microcephaly but fetal 

necropsy showed ZIKV RNA in the 

axillary lymph nodes, bone marrow, and 

optic nerve (although not in brain 

tissue). By comparison, two nonpregnant female animals no longer had 

detectable RNA at 17 days postinfection. 

Limited data from human studies also 

suggest that pregnant women have 

persistent detection of ZIKV RNA in 

serum. Symptomatic women had 

detectable virus at 17, 23, 44, and 46 

days post symptom onset and one 

asymptomatic woman was still rRT– 

PCR positive 53 days after returning 

from travel. In one symptomatic 

pregnant woman with prolonged 

detection of ZIKV RNA, the pregnancy 

ended as a fetal loss and researchers 

found ZIKV RNA in the fetus. Findings 

from these case reports and series led to 

the hypothesis that persistent detection 

of RNA in pregnant women may be a 

marker of fetal infection and thus, 

potentially a marker of adverse fetal 

outcomes including microcephaly and 

brain abnormalities. However, 

researchers need more data including 

whether the detection of IgM influences 

the risk of adverse infant outcomes. 

Researchers know even less about 

persistent detection of ZIKV RNA and 

IgM in infants. One case study reported 

persistent ZIKV RNA detection in a 

male child born in Brazil at 40 weeks 

gestation with brain abnormalities. 

Fifty-four days after birth, the infant’s 

serum, saliva, and urine all tested 

positive for ZIKV RNA; the detection of 

ZIKV RNA continued in the infant’s 

serum on day 67 and had cleared by day 

216. The infant exhibited no obvious 

illness or evidence of being 

immunocompromised when examined 

on day 54. However, he demonstrated 

neuropsychomotor developmental 

delay, with global hypertonia and 

spastic hemiplegia, by 6 months of age. 

The duration of IgM detection in infants 

is also important to determine the 

window of diagnostic utility of this test 

for infants not tested at birth. 

Due to the short window of time 

during which ZIKV RNA is typically 

detectable in serum, expanding rRT– 

PCR testing to asymptomatic women 

and women outside of the two-week 

window may provide more information 

than serologic testing alone. This is 

because positive serology does not allow 

for definitive diagnosis of infection as 

false positives and cross-reactivity with 

other flaviviruses complicates diagnosis. 

The rRT–PCR, per standard, requires a 

blood sample obtained by venipuncture 

for ZIKV RNA detection. However, 

recent unpublished data from the 

Institute Pasteur have demonstrated that 

in 57% of patients there was a 

significantly longer ZIKV RNA detection 

in capillary blood samples collected 

from Zika positive pregnant women 

tested with rRT–PCR than in venous 

samples. Similar findings from a study 

conducted during the Ebola outbreak 

showed that capillary blood samples 

can be used as an alternative to venous 

blood samples, and may be a more 

accurate method for monitoring viral 

load. 

If prolonged ZIKV RNA persistence is, 

in fact, a marker of fetal infection and 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51841 

adverse outcomes, determining the 

prevalence of prolonged detection of 

ZIKV RNA is essential for clinical 

management of pregnant women with 

ZIKV infection and public health 

planning for the outbreak. Further, 

understanding persistent ZIKV RNA in 

congenitally-exposed infants is also 

important for clinical management of 

infants and identifying adverse 

outcomes that may present several 

months after birth. Finally, 

understanding the relationship between 

persistence and viral load may inform 

clinical guidance and management of 

pregnant women and their families. 

In this study, we will estimate the 

prevalence and duration of persistent 

ZIKV RNA in pregnant women and 

congenitally exposed infants. We will 

also evaluate the diagnostic utility of 

PCR testing for ZIKV RNA on capillary 

blood and determine if persistent ZIKV 

RNA in pregnant women is associated 

with adverse outcomes or infection in 

infants. Finally, we will examine the 

association of different factors that are 

associated with persistent detection of 

ZIKV RNA in pregnant women and 

congenitally exposed infants. 

This study will provide critical data 

in establishing guidance for testing in 

pregnant women and congenitally 

exposed infants. There are no costs to 

the respondents other than their time. 

The total estimated annual burden 

hours are 785. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

ZIKV positive Pregnant women ...................... Pregnant women screening form ................... 150 1 2/60 

ZIKV positive Pregnant women ...................... Pregnant women enrollment questionnaire ... 150 1 8/60 

ZIKV positive Pregnant women ...................... Pregnant women symptom questionnaire ..... 150 1 8/60 

ZIKV positive Pregnant women ...................... Pregnant women follow-up questionnaire ...... 150 30 8/60 

ZIKV positive Pregnant women ...................... Infant enrollment and delivery questionnaire 150 1 8/60 

ZIKV positive Pregnant women ...................... Infant follow-up questionnaire ........................ 150 6 8/60 

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. 2017–24314 Filed 11–7–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–18–0931; Docket No. CDC–2017– 

0096] 

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 ‘‘Healthy Homes and Lead 

Poisoning Surveillance System 

(HHLPSS)’’. The overarching goal of the 

Healthy Homes and Lead Poisoning 

Surveillance System (HHLPSS) is to 

support healthy homes surveillance 

activities at the state and national levels. 

DATES: CDC must receive written 

comments on or before January 8, 2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2017– 

0096 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. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all Federal 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 Leroy A. 

Richardson, 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, 


ethrower on DSK3G9T082PROD with NOTICES