[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24964-24967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development 
Submission for OMB Review; Comment Request; Provider-Based Sampling 
Feasibility Study for the Vanguard (Pilot) Study and Data Collection 
Updates for the National Children's Study (NICHD)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Child Health and Human 
Development (NICHD), the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on January 30, 2012, pages 4569-4571, and allowed 60 days for 
public comment. No written comments were received. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Institutes of Health may not conduct or sponsor, and the 
respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.

Proposed Collection

    Title: Provider-Based Sampling Feasibility Study for the Vanguard 
(Pilot) Study and Data Collection Updates for the National Children's 
Study (NICHD).
    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 about 100 of the about 3,000 
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 the summer 
of 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 Federal 
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. One goal is to test the feasibility of Provider-Based 
Sampling using three study locations. Another goal is to systematically 
pilot additional study visit measures and collections to assess the 
scientific robustness, burden to participants and study infrastructure, 
and cost for use in the Vanguard (Pilot) Study and to inform the design 
of the Main Study.

Methods

Provider Based Sampling

    We will compile a list of prenatal providers serving women who 
reside within the Primary Sampling Unit at three study locations. 
Providers will be asked to complete a brief questionnaire

[[Page 24965]]

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 
largely follow the protocol and procedures developed for the Provider-
Based 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 pregnancy status at 
the initial prenatal visit. In some locations, medical records may be 
pre-screened to identify participants meeting these eligibility 
criteria.

Supplemental Information and Biospecimen Collections

    We will continue data collection with 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.
    Core Questionnaire: We propose to pilot 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 an age-
specific module alongside of the Core Questionnaire with the 30-Month 
Interview.
    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: We 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, 12, and 24-Month infant 
measures of child anthropometry and/or 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: We seek 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.
    Additional Instrument at the 24-Month Interview: The Modified 
Checklist for Autism in toddlers (M-CHAT \TM\) 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-Month Visits: Additional 
collections are needed to determine the feasibility, acceptability and 
cost of collection.
    Infant Blood and Saliva Collection at the 12-Month Visit: 
Additional collections are needed to determine the feasibility, 
acceptability and cost of collection.
    Frequency of Response: See above descriptions.
    Affected Public: Healthcare providers, pregnant women, fathers, and 
their children. The additional annualized cost to respondents over the 
three-year data collection period is estimated at annualized cost of 
$229,804. This is calculated as estimating 31,082 respondent contacts 
at an estimated average of 0.73 hours per contact, for a total 
estimated annual respondent burden as 22,791 hours. There are no 
Capital Costs to report. There are no Operating or Maintenance Costs to 
report.

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                                                                                             Estimated                                       Estimated
                                                                             Estimated       number of    Average burden     Estimated     total annual
         Data collection activity                Type of respondent          number of     responses per   per response    total annual     respondent
                                                                            respondents     respondent      (in hours)     burden hours        cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Screening Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Provider Based Sampling Eligibility         Pregnant Women..............           3,125               1           20/60           1,042         $10,417
 Screener (PBS)
Provider Based Sampling Frame               Healthcare Providers                      50               1           25/60              21           2,104
 Questionnaire (PBS)
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                                                                  Continuous Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonrespondent Questionnaire (PB, EH, TT-    Pregnant Women, Mothers or               480               1            5/60              40             400
 HI, TT-LI, PBS)                             Fathers
Validation Interview--up to 30 Months (PB,  Respondents.................           1,268               1            5/60             106          $1,057
 EH, TT-HI, TT-LI, PBS).
Participant Verification (PB, EH, TT-HI,    Pregnant Women, Mothers or             2,320               1            5/60             193           1,933
 TT-LI, PBS).                                Fathers.
Tracing Interview (PB, EH, TT-HI, TT-LI,    Respondents.................           1,167              13           10/60           2,528          25,281
 PBS).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Pregnancy Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low-intensity Questionnaire (Found          Pregnant Women..............             173               1           15/60              43             432
 Pregnant) (TT-LI).

[[Page 24966]]

 
Pregnancy Visit 1 Interview (PB, EH, TT-    Pregnant Women..............           2,018               1           35/60           1,177          11,774
 HI, PBS).
Pregnancy Visit 2 Interview (PB, EH, TT-    Pregnant Women..............           1,817               1           25/60             757           7,569
 HI, PBS).
Biological and Environmental Sample         Pregnant Women..............           1,456               2           60/60           2,913          29,127
 Collection--Prenatal (PB, EH, TT-HI).
Pregnancy Health Care Log (PB, EH, TT-HI,   Pregnant Women..............           1,615               1           20/60             538           5,382
 PBS).
Father Interview (PB, EH, TT-HI)..........  Alternate Caregiver.........             818               1           35/60             477           4,770
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Birth-Related Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Birth Visit Interview (PB, EH, TT-HI, PBS)  Mother/Baby.................           1,141               1           20/60             380           3,802
Low-intensity Questionnaire (Birth-focus)   Mother/Baby.................             432               1           15/60             108           1,080
 (TT-LI).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Postnatal Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant Feeding Log (PB, EH, TT-HI, PBS)...  Mother/Baby.................           1,106               1           20/60             369           3,688
Biological Sample Collection--Mother/Baby   Mother/Baby.................             761               4         22.5/60           1,141          11,411
 (PB, EH, TT-HI).
3-Month Interview (PB, EH, TT-HI, TT-LI,    Mother/Baby.................           1,518               1           20/60             506           5,061
 PBS).
6-Month Interview (PB, EH, TT-HI, PBS)....  Mother/Baby.................           1,066               1           30/60             533           5,331
Physical Measures--Child Anthropometry (6-  Baby/Child..................             701               3           20/60             701           7,014
 ,12-, 24-Month) (PB, EH, TT-HI).
Physical Measures--Child Blood Pressure     Baby/Child..................             675               2           10/60             225           2,250
 (12-, 24-Month) (PB, EH, TT-HI).
9-Month Interview (PB, EH, TT-HI, TT-LI,    Mother/Baby.................           1,428               1           10/60             238           2,381
 PBS).
12-Month Interview (PB, EH, TT-HI, PBS)...  Mother/Baby.................           1,003               1           50/60             836           8,360
18-Month Interview (PB, EH, TT-HI, TT-LI,   Mother/Child................           1,316               1           30/60             658           6,582
 PBS).
24-Month Interview (PB, EH, TT-HI, TT-LI,   Mother/Child................           1,251               1           35/60             729           7,295
 PBS).
Core Questionnaire (PB, EH, TT-HI, TT-LI,   Mother/Child................           1,188               1           30/60             594           5,940
 PBS).
30-Month Visit Interview (PB, EH, TT-HI,    Mother/Child................           1,188               1           55/60           1,089          10,890
 TT-LI, PBS).
                                           -------------------------------------------------------------------------------------------------------------
    Total, Vanguard (Pilot) Study.........  ............................          31,082  ..............  ..............          17,943         181,331
                                           -------------------------------------------------------------------------------------------------------------
    Total, Formative Research.............  ............................  ..............  ..............  ..............           4,847          48,473
                                           -------------------------------------------------------------------------------------------------------------
        Grand Total.......................  ............................          31,082  ..............  ..............          22,791         229,804
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 enhance the quality, utility, and 
clarity of the information 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to Office of Management and Budget, Office of Information and 
Regulatory Affairs, Attn: NIH Desk Officer, by Email to [email protected], or by fax to (202) 395-6974. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and instruments, contact Ms. Jamelle E. Banks, Public 
Health Analyst, Office of Science Policy, Analysis and Communication, 
National Institute of Child Health and Human Development, 31 Center 
Drive, Room 2A18, Bethesda,

[[Page 24967]]

Maryland 20892, or call a 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 30 days 
of the date of this publication.

    Dated: April 16, 2012.
Jamelle E. Banks,
Project Clearance Liaison, Office of Science Policy, Analysis and 
Communications, National Institute of Child Health and Human 
Development.
[FR Doc. 2012-10113 Filed 4-25-12; 8:45 am]
BILLING CODE 4140-01-P