[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4569-4571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Revision to Proposed Collection; Comment Request; National 
Institute of Child Health and Human Development; the National 
Children's Study, Vanguard (Pilot) Study

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 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.

Proposed Collection

    Title: The National Children's Study, Vanguard (Pilot) Study.
    Type of Information Collection Request: Revision.
    Need and Use of Information Collection: The purpose of the proposed 
methodological study is to continue the Vanguard phase of the National 
Children's Study with updated instruments and additional biospecimen 
collections and physical measures and to evaluate the feasibility, 
acceptability, and cost of a different sampling strategy for enrollment 
of pregnant women. This study is one component of a larger group of 
studies being conducted during the Vanguard Phase of the National 
Children's Study (NCS), a prospective, national longitudinal study of 
child health and development. In combination, these studies will be 
used to 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 sample frame for the NCS Vanguard and 
Main Study was initially based on a national probability sample using 
geography as the basis and selecting about100 of the about 3000 
counties in the United States as the basis for Primary Sampling Units. 
Within the Primary Sampling Units, smaller geographic segments were 
selected as Secondary Sampling Units in an attempt to normalize live 
birth rates per area sampled. Women who resided at the time of 
enrollment within a designated Secondary Sampling Unit and were either 
pregnant or between 18 and 49 were eligible for enrollment. The initial 
recruitment technique within the selected geographic areas was 
household contact by field workers going door to door.
    The Vanguard Study was launched in January 2009, and by summer 
2009, field experience suggested that the household contact recruitment 
strategy was not feasible with available resources. Thus, in 2010 new 
recruitment strategies were launched to evaluate options. By late 2011, 
the NCS had sufficient data to evaluate operational aspects of various 
recruitment strategies. Preliminary analyses suggested that a provider 
based recruitment strategy was the most efficient, but due to 
constrictions of the geographic sampling frame, the potential of the 
strategy was limited. Specifically, many women had to be screened at a 
particular provider to locate the relatively few who resided in a 
designated segment. Anticipating this limitation, the NCS Program 
Office developed and discussed with the NCS Advisory Committee a 
different sampling frame, using provider location. This new sampling 
strategy is termed Provider Based Sampling (PBS). Information from this 
data collection is critical to determine the plausibility of a provider 
based sampling frame as an option for some parts of the NCS Main Study.

Research Questions

    Two research goals will be accomplished by this information 
collection. The first goal is to systematically pilot additional study 
visit measures and collections whose scientific robustness, burden to 
participants and study infrastructure, and cost for use in the Vanguard 
(Pilot) Study and to inform the Main Study. The second goal is to test 
the feasibility, acceptability, and cost of Provider Based Sampling 
using three locations.

Methods

    We will continue with the current data collection schedule which 
include pre-pregnancy, pregnancy, and birth periods, as well as 
postnatal data collection points at 3, 6, 9, 12, 18, and 24 months of 
age. 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.

Supplemental Information and Biospecimen Collections

    Core Questionnaire: We propose to pilot use of a 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.
    30-Month Data Collection Module: We propose piloting the approach 
of use of a core instrument plus an age specific module with the 30 
month visit.
    Validation Questions for 18, 24 and 30 month: We propose addition 
of brief, telephone-based questions that would be fielded to a random 
sample of each interviewer's cases after completion of the 18-Month, 
24-Month, and 30-Month interviews to monitor interviewer performance 
and identify occurrences of data falsification.
    Nonrespondent Questionnaire will collect information on why a 
participant chose to not enroll or withdraw from the NCS. This 
information may be used to revise our approaches to recruitment and 
will help the Study frame other systematic analyses of nonresponse 
bias.
    Physical Measures: The addition of 6 month and 12 month infant 
measures of child anthropometry and blood pressure may provide critical 
pieces of information for future research on the causes of obesity, 
diabetes, premature puberty and a host of other health outcomes.
    Revised Father Questionnaire: The NCS seeks to incorporate 
behavioral, emotional, educational and contextual consequences to 
enable a complete assessment of psychosocial influences on children's 
well-being. The Revised Father Questionnaire now includes measures 
addressing key social/personal resources and fathers' capacity, desire 
and attitudes towards engaging with mothers and children.

[[Page 4570]]

    Revised 24 Month Interview: The Modified Checklist for Autism in 
toddlers (M-CHATTM) is a validated brief screening measure 
for identification of Autism and will be added to the 24 month 
interview.
    Breast Milk Collection 1 and 3 months: Additional collections are 
needed to determine the feasibility, acceptability and cost of 
collection.
    Infant Urine Collection at 6 and 12 months: Additional collections 
are needed to determine the feasibility, acceptability and cost of 
collection.
    Infant Blood and Saliva Collection at 12 months: Additional 
collections are needed to determine the feasibility, acceptability and 
cost of collection.

Provider Based Sampling

    We will compile, at three Vanguard Study locations, a list of 
prenatal providers serving women who reside in the Primary Sampling 
Unit. Providers will be asked to complete a brief questionnaire about 
their practice and their patient demographics. For this pilot, a woman 
will be eligible for recruitment if she resides in the Primary Sampling 
Unit and is seeing a provider for her first prenatal visit.
    Recruitment of participants at the selected provider offices will 
follow the protocol and procedures developed for the Provider-Based 
Sample Recruitment Substudy, as previously approved by the Office of 
Information and Regulatory Affairs within the Office of Management and 
Budget. Potential participants will be screened on age eligibility, 
residence in the sampled Primary Sampling Unit, and status of an 
initial prenatal visit. In some locations, medical records may be 
prescreened to identify participants meeting these eligibility 
criteria.
    Frequency of Response: See above descriptions.
    Affected Public: Healthcare Providers, Age-eligible women, Pregnant 
women, Fathers, and their children.
    Annual Reporting Burden: See Table 1. The additional annualized 
cost to respondents over the 3 year data collection period is estimated 
at annualized cost of $1,966,069 (based on $10 per hour). This is 
calculated as estimating 415,894 respondent contacts at an estimated 
average of 0.47 hours per contact, for a total estimated annual 
respondent burden as 196,607 hours. There are no Capital Costs to 
report. There are no Operating or Maintenance Costs to report.

 Table 1--Estimated Annual Reporting Burden for Recruitment Substudy Respondents, Prenatal to 30 Months, Phase 2
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                     Type of         Estimated       number of        Average        Estimated
   Data collection activity        respondent        number of     responses per   burden hours    total annual
                                                    respondents     respondent     per response    burden hours
----------------------------------------------------------------------------------------------------------------
Pregnancy Screener (PB, EH, TT- Age-Eligible              68,538               1            0.42          28,558
 HI).                            Women.
Provider Based Sampling         Age-Eligible               9,375               1            0.25           2,344
 Eligibility Screener (PBS).     Women.
Healthcare Provider             Healthcare                   600               1            0.17             100
 Questionnaire (PB).             Providers.
Provider Based Sampling Frame   Healthcare                 1,225               1            0.17             204
 Questionnaire (PBS).            Providers.
Household Enumeration           HH Reporters....         120,000               1            0.33          40,000
 Instrument (EH).
Low-intensity Invitation to     Age-Eligible              15,840               1            0.25           3,960
 High-intensity Script (TT-HI).  Women.
Pregnancy Screener (TT-LI, TT-  Age-Eligible              48,000               1            0.35          16,800
 HI).                            Women.
Low-Intensity Consent Script    Age-Eligible              28,800               1            0.33           9,600
 (TT-LI).                        Women.
Nonrespondent Questionnaire     Pregnant Women,            3,000               1            0.08             250
 (PB, EH, TT-HI, TT-LI, PBS).    Non-Pregnant
                                 Women, Mothers
                                 or Fathers.
Preconception Activities:
    Non-pregnant Women's        Age-Eligible               1,825               1            0.50             913
     Informed Consent (PB, EH,   Women.
     TT-HI).
    Pre-Pregnancy Interview     Age-Eligible               1,095               1            0.75             821
     (PB, EH, TT-HI).            Women.
    Biological and              Age-Eligible                 986               1            0.25             246
     Environmental Sample        Women.
     Collection--Preconception
     (PB, EH, TT-HI).
    Pregnancy Probability       Age-Eligible              11,152               6            0.10           6,691
     Group Follow Up Script      Women.
     (PB, EH, TT-HI, TT-LI).
    Low-intensity               Age-Eligible              10,057               1            0.50           5,029
     Questionnaire (Non-         Women.
     Pregnant) (TT-LI).
    Validation Script (PB, EH,  Age-Eligible               3,805               1            0.08             304
     TT-HI, TT-LI, PBS).         Women.
Pregnancy Activities:
    Pregnant Women's Informed   Pregnant Women..          12,967               1            0.50           6,484
     Consent Form (PB, EH, TT-
     HI, PBS).
    Low-intensity               Pregnant Women..             518               1            0.50             259
     Questionnaire (Found
     Pregnant) (TT-LI).
    Pregnancy Visit 1           Pregnant Women..           6,310               1            1.00           6,310
     Interview (PB, EH, TT-HI,
     PBS).
    Biological and              Pregnant Women..          10,363               1            0.25           2,591
     Environmental Sample
     Collection--Pregnancy
     (PB, EH, TT-HI, PBS).
    Pregnancy Visit 2           Pregnant Women..           6,190               1            0.75           4,643
     Interview (PB, EH, TT-HI,
     PBS).
    1Pregnancy Health Care Log  Pregnant Women..           5,048               1            0.33           1,683
     (PB, EH, TT-HI, PBS).
    Father Informed Consent     Alternate                  5,048               1            0.50           2,524
     Form (PB, EH, TT-HI, PBS).  Caregiver.
    Father Interview (PB, EH,   Alternate                  3,029               1            0.25             757
     TT-HI, PBS).                Caregiver.

[[Page 4571]]

 
Birth-Related Activities:
    Birth Visit Interview (PB,  Mother/Baby.....           3,422               1            0.40           1,369
     EH, TT-HI, PBS).
    Low-intensity               Mother/Baby.....           1,296               1            0.50             648
     Questionnaire (Birth-
     focus) (TT-LI).
Postnatal Activities:
    Infant Feeding Log (PB,     Mother/Baby.....           3,319               1            0.33           1,106
     EH, TT-HI, PBS).
    Low-intensity               Mother/Baby.....           1,147               4            0.50           2,295
     Questionnaire (Child-
     focus) (TT-LI).
    Biological Sample           Mother/Baby.....          11,635               1            1.50          17,452
     Collection--Mother/Baby
     (PB, EH, TT-HI, PBS).
    3-Month Interview (PB, EH,  Mother/Baby.....           3,298               1            0.33           1,099
     TT-HI, PBS).
    Core Questionnaire (PB,     Mother/Child....           2,911               6            0.30           5,240
     EH, TT-HI, TT-LI, PBS).
    6-Month Visit Interview     Mother/Baby.....           3,199               1            0.50           1,599
     (PB, EH, TT-HI, PBS).
    Physical Measures (6-       Baby/Child......           2,677               3            0.50           4,016
     Month, 12-Month, 24-
     Month).
    9-Month Interview (PB, EH,  Mother/Baby.....           3,103               1            0.17             517
     TT-HI, PBS).
    12-Month Visit Interview    Mother/Baby.....           3,010               1            0.50           1,505
     (PB, EH, TT-HI, PBS).
    18-Month Interview (PB,     Mother/Child....           2,859               1            0.50           1,430
     EH, TT-HI, PBS).
    24-Month Interview (PB,     Mother/Child....           2,716               1            0.75           2,037
     EH, TT-HI, PBS).
    30-Month Visit Interview    Mother/Child....           2,580               1            0.92           2,365
     (PB, EH, TT-HI, TT-LI,
     PBS).
Formative Research:
    Formative--Developmental..  ................  ..............  ..............  ..............          14,542
                               ---------------------------------------------------------------------------------
        Grand Total, Alternate  ................         415,894  ..............  ..............         182,065
         Recruitment Substudy.
        Total, Formative        ................  ..............  ..............  ..............          14,542
         Research.
                               ---------------------------------------------------------------------------------
        Grand Total...........  ................         415,894  ..............  ..............         196,607
----------------------------------------------------------------------------------------------------------------

    Request for Comments: 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 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Jamelle E. Banks, Project Clearance Liaison, 
Office of Science Policy, Analysis and Communication, National 
Institute of Child Health and Human Development, 31 Center Drive Room 
2A18, Bethesda, Maryland, 20892, or call non-toll free number (301) 
496-1877 or Email your request, including your address to 
[email protected].
    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.

    Dated: January 19, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science Policy, Analysis and 
Communications, National Institute of Child Health and Human 
Development.
[FR Doc. 2012-1934 Filed 1-27-12; 8:45 am]
BILLING CODE 4140-01-P