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The National Children's Study, Vanguard (Pilot) Study Proposed Collection; 60-day Comment Request

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SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-7898 or Email your request, including your address to glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

Proposed Collection: The National Children's Study, Vanguard (Pilot) Study, 0925-0593, Expiration 8/31/2014—Revision, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH).

Need and Use of Information Collection: The purpose of this request is to continue data collection activities for the NCS Vanguard Study and receive a renewal of the Vanguard Study clearance. The NCS also proposes the initiation of a new enrollment cohort, the addition of new Study visits, revisions to existing Study visits, and the initiation of methodological substudies. The NCS Vanguard Study is a prospective, longitudinal pilot study of child health and development that will inform the design of the Main Study of the National Children's Study.

Background: The National Children's Study is a prospective, national longitudinal study of the interaction between environment, genetics on child health, and development. The Study defines “environment” broadly, taking a number of natural and man-made environmental, biological, genetic, and psychosocial factors into account. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible. The National Children's Study (NCS) has several components, including a pilot or Vanguard Study, and a Main Study to collect exposure and outcome data.

The NCS Vanguard Study continues to follow the children and families enrolled in the Vanguard Study, conducting Study visits in participants' homes and over the telephone. Data Collection visits may include the administration of questionnaires, neurodevelopmental assessments, physical measures, and the collection of biospecimens and environmental measures. The Vanguard Study has yielded valuable data and field experience related to participant recruitment, the conduct of Study assessments, and operational requirements associated with NCS infrastructure and field efforts. The purpose of the proposed data collection is to obtain further operational and performance data on processes and administration Study visit measures.

Research Questions: The primary research goal is to systematically pilot additional study visit measures and collections for scientific robustness, burden to participants and study infrastructure, and cost for use in the Vanguard (Pilot) Study and to inform the Main Study. A secondary goal is to increase enrollment in the Vanguard Study through the identification of subsequent pregnancies among enrolled women.

Methods: The NCS Vanguard Study data collection schedule includes pre-pregnancy, pregnancy, and birth periods, as well as post-natal collection points at defined intervals between 3 and 60 months. We propose to add or modify the selected measures below to address analytic goals of assessing feasibility, acceptability, and cost of specific study visit measures.

Enrollment of Sibling Birth Cohort: We will enroll approximately 1,000 sibling births identified among currently enrolled women. Following new pregnancies will allow us to pilot the collection of biospecimens, environmental samples, and standardized neurodevelopmental assessments on sufficient numbers of participants to understand what activities are feasible in specific settings, participants' willingness to complete requested measures, and whether measures are useful and scalable. Participants will be administered the same protocol as approved for the NCS Vanguard Study by the Office of Information and Regulatory Affairs within the Office of Start Printed Page 52549Management and Budget, including the collection of environmental samples, biospecimens and physical measurements during pre-pregnancy and pre- and post-natal visits. Those who report that they are trying to conceive will be initially administered the protocols approved for preconception data collection. Others who self-report a pregnancy at a later time will receive pregnancy visit instrumentation and collections.

Supplemental Information Collections

Core Questionnaire: We propose a revised core questionnaire containing key variables and designed to collect core data at every study visit contact from the time that the enrolled child is 6 months of age to the time the child is 5 years of age.

Age-Specific Modular Questionnaires: At each Study visit, participants will be administered brief questionnaire modules that include measures relevant to the specific age of the enrolled child.

Biospecimen Collections: Microbiome swabs will be collected from NCS children from the nasal cavity, inside of the elbow, and rectum at two time points. Shed deciduous teeth will be collected from NCS children beginning at age five. Instructions on retrieval and shipment and to postage-paid shipping materials will be provided to participants. We propose to provide $10 per shed deciduous tooth collected and shipped.

Environmental Sample Collection: Noise measurements will be taken at the homes of randomly-selected enrolled participants. With their consent, their homes will be equipped with a noise meter and measured for noise levels at various time intervals, and data collectors will ask questions about the source and frequency of noise they encounter at home.

Physical Measures: BIA, or bioelectrical impedance analysis, is a non-invasive method for estimation of body composition including Body Mass Index. BIA will be measured on a small subsample of approximately 200 NCS children. For comparison, conventional skinfold measurements using previously approved and implemented protocols will be collected. Physical activity in children will be measured with accelerometers at three data collection points with a subsample of approximately 600 NCS enrolled children. Participants will be asked to wear the Actigraph GT3X-plus physical activity monitor on their wrist for a 7-day period. Once the monitor has been returned, a check for $25 will be mailed to the participant as a token of appreciation for their time. Pulmonary function will be measured at age five through spirometry, a simple, non-invasive method.

NIH Toolbox Measures: The NIH Toolbox (www.nihtoolbox.org) is a series of short assessments designed to measure emotional, cognitive, sensory, and motor function in children as young as age three.

Assessing Participant Experience: NCS participants will be asked to complete self-administered questionnaires designed to assess feelings towards the NCS and motivation to be engaged in research. Through the use of these instruments, the NCS aims to maintain positive relationships with participants and allow them to provide useful feedback about the Study, its procedures and perceived value to them, their families, and communities.

Retrospective Pregnancy Questionnaire: Women who joined the NCS after the birth of the enrolled child will be asked to complete a Retrospective Pregnancy Questionnaire designed to collect prenatal medical information.

OMB approval is requested for 3 years. The additional annualized cost to respondents over the 3 year data collection period is estimated at an annualized cost of $633,541 (based on $10 per hour). The total estimated annualized burden hours are 63,354 hours (see Table 1).

Estimated Annualized Burden Hours for Vanguard (Pilot) Study Respondents, Study Visits Through 60 Months of Age of the Child

Data collection activityType of respondentEstimated number of respondentsEstimated number of responses per respondentAverage burden per response (in hrs)Estimated total annual burden hours
Screening Activities:
Pregnancy Status Screener (Sibling Birth Cohort) (9M to 60M)Biological Mother1,072103/60536
Retrospective Pregnancy Screener (Birth or 3M or 6M)Biological Mother422139/60274
Continuous Activities:
Participant Verification, Scheduling, & Tracing Interview (PVST) (PV1 to 60M)Biological Mother, Primary Caregiver, Secondary Caregiver, Adult Caregiver-Identified Father843159/601,898
Parent-Caregiver Death Questionnaire (3M to 60M)Secondary Caregiver312/600.17
Child Death Questionnaire (3M to 60M)Primary Caregiver413/600.22
Participant Information Update SAQ—Incentive Substudy (24M to 60M)Primary Caregiver, Secondary Caregiver1,29273/60754
Validation Questionnaire (Pre-Pregnancy to 60M)Primary Caregiver, Secondary Caregiver818165/60436
Non-Interview Respondent (NIR) SAQ (Pre-Pregnancy to 60M)Biological Mother, Primary Caregiver, Secondary Caregiver, Adult Caregiver-Identified Father99815/6083
Preconception Activities:
Pre-Pregnancy InterviewBiological Mother440140/60293
Adult-Focused Biospecimen Collection—Blood & UrineBiological Mother, Primary Caregiver, Secondary Caregiver352124/60141
Pregnancy Probability Group Follow-upBiological Mother440115/60110
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Prenatal Activities:
Pregnancy Visit 1 InterviewBiological Mother, Primary Caregiver, Secondary Caregiver333138/60211
Pregnancy Visit 2 InterviewBiological Mother333116/6089
Adult-Focused Biospecimen Collection—Blood & Urine (PV1, PV2)Biological Mother, Primary Caregiver, Secondary Caregiver267224/60213
Environmental Sample Collection—Vacuum Bag Dust (PV1)Primary Caregiver, Secondary Caregiver28313/6014
Father Pre-Natal Interview (PV1 or PV2)Adult-Caregiver Identified Father317129/60153
Pregnancy Health Care Log (PV1 or PV2)Biological Mother33315/6028
Pregnancy Loss, Stillbirth, & Neonatal Death InterviewBiological Mother13135/608
Birth-Related Activities:
Birth InterviewPrimary Caregiver, Secondary Caregiver317115/6079
Pregnancy Loss, Stillbirth, & Neonatal Death InterviewBiological Mother13135/607
Adult-Focused Biospecimen Collection—Blood, Urine, Cord Blood, Breast Milk, & PlacentaBiological Mother, Primary Caregiver, Secondary Caregiver253134/60144
Child25313/6013
Child-Focused Biospecimen Collection—Infant Blood Spot & Microbiome SwabPrimary Caregiver, Secondary Caregiver253120/6084
Postnatal Activities:
Infant Child Health Care Log (Birth to 60M)Primary Caregiver, Secondary Caregiver2,05015/60171
3-Month InterviewBiological Mother, Primary Caregiver, Secondary Caregiver475139/60309
Adult-Focused Biospecimen Collection—Breast Milk, Blood, Urine, & Saliva (3M, 6M, 12M, 36M, 60M)Biological Mother, Primary Caregiver, Secondary Caregiver8071143/606,364
6-Month InterviewPrimary Caregiver, Secondary Caregiver475138/60301
Core Questionnaire—Child, Adult Caregiver, & Household (6M to 60M, except 9M)Primary Caregiver, Secondary Caregiver1,0641030/605,320
Child-Focused Biospecimen Collection—Urine, Blood, Saliva, Microbiome Swab & Teeth (6M, 12M, 36M, 48M, 60M)Biological Mother, Primary Caregiver, Secondary Caregiver9001267/6012,064
9-Month InterviewPrimary Caregiver, Secondary Caregiver55415/6046
Father/Father Figure Post-Natal Questionnaire (9M or 18M)Adult-Caregiver Identified Father558117/60158
12-Month InterviewPrimary Caregiver, Secondary Caregiver554145/60416
Child-Focused Physical Measures—Anthropometry, Blood Pressure, Vision Screening, Lung Function, & Motor Skills (6M, 12M, 24M, 36M, 48M, 60M)Primary Caregiver, Secondary Caregiver9521563/6014,989
Environmental Sample Collection—Vacuum Bag Dust, Indoor and Outdoor Visual Observations, & Dust Wipes (12M, 36M, 48M, 60M)Primary Caregiver, Secondary Caregiver1,0461415/603,660
18-Month InterviewPrimary Caregiver, Secondary Caregiver562147/60440
24-Month InterviewPrimary Caregiver, Secondary Caregiver1,046130/60523
30-Month InterviewPrimary Caregiver, Secondary Caregiver1,009159/60992
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36-Month InterviewPrimary Caregiver, Secondary Caregiver1,434194/602,247
42-Month InterviewPrimary Caregiver, Secondary Caregiver1,325147/601,038
48-Month InterviewPrimary Caregiver, Secondary Caregiver1,3801103/602,369
54-Month InterviewPrimary Caregiver, Secondary Caregiver1,431123/60549
60-Month InterviewPrimary Caregiver, Secondary Caregiver1,4211103/602,439
Subsample Studies:
Noise (36M, 60M)Primary Caregiver, Secondary Caregiver200217/60113
Bioelectrical Impedance Analysis (BIA) (48M, 60M)Primary Caregiver, Secondary Caregiver6725/6011
Physical Activity (Accelerometer) (36M, 48M, 60M)Primary Caregiver, Secondary Caregiver200343/60430
Total Vanguard (Pilot) Study60,519
Total Formative Research2,8352,835
Grand Total Vanguard (Pilot) Study29,16663,354
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Dated: August 14, 2013.

Sarah L. Glavin,

Deputy Director, Office of Science Policy, Analysis, and Communications Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health.

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[FR Doc. 2013-20549 Filed 8-22-13; 8:45 am]

BILLING CODE 4140-01-P