[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Pages 52548-52551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

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 
[email protected]. 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

[[Page 52549]]

Management 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
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated        Average
                                     Type of         Estimated       number of      burden per       Estimated
   Data collection activity        respondent        number of     responses per   response  (in   total annual
                                                    respondents     respondent         hrs)        burden hours
----------------------------------------------------------------------------------------------------------------
Screening Activities:
    Pregnancy Status Screener   Biological                 1,072              10            3/60             536
     (Sibling Birth Cohort)      Mother.
     (9M to 60M).
    Retrospective Pregnancy     Biological                   422               1           39/60             274
     Screener (Birth or 3M or    Mother.
     6M).
Continuous Activities:
    Participant Verification,   Biological                   843              15            9/60           1,898
     Scheduling, & Tracing       Mother, Primary
     Interview (PVST) (PV1 to    Caregiver,
     60M).                       Secondary
                                 Caregiver,
                                 Adult Caregiver-
                                 Identified
                                 Father.
    Parent-Caregiver Death      Secondary                      3               1            2/60            0.17
     Questionnaire (3M to 60M).  Caregiver.
    Child Death Questionnaire   Primary                        4               1            3/60            0.22
     (3M to 60M).                Caregiver.
    Participant Information     Primary                    1,292               7            3/60             754
     Update SAQ--Incentive       Caregiver,
     Substudy (24M to 60M).      Secondary
                                 Caregiver.
    Validation Questionnaire    Primary                      818              16            5/60             436
     (Pre-Pregnancy to 60M).     Caregiver,
                                 Secondary
                                 Caregiver.
    Non-Interview Respondent    Biological                   998               1            5/60              83
     (NIR) SAQ (Pre-Pregnancy    Mother, Primary
     to 60M).                    Caregiver,
                                 Secondary
                                 Caregiver,
                                 Adult Caregiver-
                                 Identified
                                 Father.
Preconception Activities:
    Pre-Pregnancy Interview...  Biological                   440               1           40/60             293
                                 Mother.
    Adult-Focused Biospecimen   Biological                   352               1           24/60             141
     Collection--Blood & Urine.  Mother, Primary
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Pregnancy Probability       Biological                   440               1           15/60             110
     Group Follow-up.            Mother.

[[Page 52550]]

 
Prenatal Activities:
    Pregnancy Visit 1           Biological                   333               1           38/60             211
     Interview.                  Mother, Primary
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Pregnancy Visit 2           Biological                   333               1           16/60              89
     Interview.                  Mother.
    Adult-Focused Biospecimen   Biological                   267               2           24/60             213
     Collection--Blood & Urine   Mother, Primary
     (PV1, PV2).                 Caregiver,
                                 Secondary
                                 Caregiver.
    Environmental Sample        Primary                      283               1            3/60              14
     Collection--Vacuum Bag      Caregiver,
     Dust (PV1).                 Secondary
                                 Caregiver.
    Father Pre-Natal Interview  Adult-Caregiver              317               1           29/60             153
     (PV1 or PV2).               Identified
                                 Father.
    Pregnancy Health Care Log   Biological                   333               1            5/60              28
     (PV1 or PV2).               Mother.
    Pregnancy Loss,             Biological                    13               1           35/60               8
     Stillbirth, & Neonatal      Mother.
     Death Interview.
Birth-Related Activities:
    Birth Interview...........  Primary                      317               1           15/60              79
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Pregnancy Loss,             Biological                    13               1           35/60               7
     Stillbirth, & Neonatal      Mother.
     Death Interview.
    Adult-Focused Biospecimen   Biological                   253               1           34/60             144
     Collection--Blood, Urine,   Mother, Primary
     Cord Blood, Breast Milk,    Caregiver,
     & Placenta.                 Secondary
                                 Caregiver.
                                Child...........             253               1            3/60              13
    Child-Focused Biospecimen   Primary                      253               1           20/60              84
     Collection--Infant Blood    Caregiver,
     Spot & Microbiome Swab.     Secondary
                                 Caregiver.
Postnatal Activities:
    Infant Child Health Care    Primary                    2,050               1            5/60             171
     Log (Birth to 60M).         Caregiver,
                                 Secondary
                                 Caregiver.
    3-Month Interview.........  Biological                   475               1           39/60             309
                                 Mother, Primary
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Adult-Focused Biospecimen   Biological                   807              11           43/60           6,364
     Collection--Breast Milk,    Mother, Primary
     Blood, Urine, & Saliva      Caregiver,
     (3M, 6M, 12M, 36M, 60M).    Secondary
                                 Caregiver.
    6-Month Interview.........  Primary                      475               1           38/60             301
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Core Questionnaire--Child,  Primary                    1,064              10           30/60           5,320
     Adult Caregiver, &          Caregiver,
     Household (6M to 60M,       Secondary
     except 9M).                 Caregiver.
    Child-Focused Biospecimen   Biological                   900              12           67/60          12,064
     Collection--Urine, Blood,   Mother, Primary
     Saliva, Microbiome Swab &   Caregiver,
     Teeth (6M, 12M, 36M, 48M,   Secondary
     60M).                       Caregiver.
    9-Month Interview.........  Primary                      554               1            5/60              46
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Father/Father Figure Post-  Adult-Caregiver              558               1           17/60             158
     Natal Questionnaire (9M     Identified
     or 18M).                    Father.
    12-Month Interview........  Primary                      554               1           45/60             416
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Child-Focused Physical      Primary                      952              15           63/60          14,989
     Measures--Anthropometry,    Caregiver,
     Blood Pressure, Vision      Secondary
     Screening, Lung Function,   Caregiver.
     & Motor Skills (6M, 12M,
     24M, 36M, 48M, 60M).
    Environmental Sample        Primary                    1,046              14           15/60           3,660
     Collection--Vacuum Bag      Caregiver,
     Dust, Indoor and Outdoor    Secondary
     Visual Observations, &      Caregiver.
     Dust Wipes (12M, 36M,
     48M, 60M).
    18-Month Interview........  Primary                      562               1           47/60             440
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    24-Month Interview........  Primary                    1,046               1           30/60             523
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    30-Month Interview........  Primary                    1,009               1           59/60             992
                                 Caregiver,
                                 Secondary
                                 Caregiver.

[[Page 52551]]

 
    36-Month Interview........  Primary                    1,434               1           94/60           2,247
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    42-Month Interview........  Primary                    1,325               1           47/60           1,038
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    48-Month Interview........  Primary                    1,380               1          103/60           2,369
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    54-Month Interview........  Primary                    1,431               1           23/60             549
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    60-Month Interview........  Primary                    1,421               1          103/60           2,439
                                 Caregiver,
                                 Secondary
                                 Caregiver.
Subsample Studies:
    Noise (36M, 60M)..........  Primary                      200               2           17/60             113
                                 Caregiver,
                                 Secondary
                                 Caregiver.
    Bioelectrical Impedance     Primary                       67               2            5/60              11
     Analysis (BIA) (48M, 60M).  Caregiver,
                                 Secondary
                                 Caregiver.
    Physical Activity           Primary                      200               3           43/60             430
     (Accelerometer) (36M,       Caregiver,
     48M, 60M).                  Secondary
                                 Caregiver.
                               ---------------------------------------------------------------------------------
        Total Vanguard (Pilot)  ................  ..............  ..............  ..............          60,519
         Study.
                               ---------------------------------------------------------------------------------
        Total Formative         ................           2,835  ..............  ..............           2,835
         Research.
                               ---------------------------------------------------------------------------------
        Grand Total Vanguard    ................          29,166  ..............  ..............          63,354
         (Pilot) Study.
----------------------------------------------------------------------------------------------------------------


    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.
[FR Doc. 2013-20549 Filed 8-22-13; 8:45 am]
BILLING CODE 4140-01-P