[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65049-65050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22597]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Child Health and Human Development; 
Proposed Collection; Comment Request; Pilot Study for the National 
Children's 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: Pilot Study for the National Children's 
Study, Type of Information Collection Request: NEW, Affected entities: 
Households and individuals. Types of respondents: People potentially 
affected by this action are pregnant women, women age 18-49 years of 
age, their husbands or partners, and their children who live in 
selected areas within the seven (7) National Children's Study Vanguard 
sites enumerated below. A small number of health care professionals, 
community leaders, and child care personnel are also potential 
respondents. Frequency of Response: On occasion. See burden table for 
estimated number of annual responses for each respondent. Need and use 
of information collection: The purpose of this Study is to pilot test 
protocols, policies, and procedures for the National Children's Study 
(NCS) with the goal of improving the efficiency of study procedures and 
enhancing the subsequent implementation of the NCS. The NCS is a long-
term cohort study of environmental influences on child health and 
development authorized under the Children's Health Act of 2000. The Act 
specifies a broad definition of environment, including biologic, 
chemical, physical, and psycho-social factors and authorizes NICHD to 
plan, develop, and implement a prospective cohort study, from birth to 
adulthood, to evaluate the effects of those exposures on child health 
and human development. This data collection will test procedures for 
population-based sampling and recruitment of pregnant women and women 
of child-bearing age, test study logistics, and estimates of subject 
burden, and evaluate data collection strategies including interviews 
and acquisition of biologic and environmental samples. In addition, 
participants will also be asked to provide qualitative and quantitative 
input on their feelings regarding participation in this Study, to 
enhance the lessons that can be learned and applied to improve the 
efficiency of the full NCS. Further details pertaining to the NCS 
background and planning, including the NCS Research Plan, can be found 
at: http://nationalchildrensstudy.gov. This Pilot Study will be carried 
out in the seven NCS ``Vanguard'' locations previously selected as the 
initial study sites. These sites are Orange County, CA; Duplin County, 
NC; Queens County, NY; Montgomery County, PA; Salt Lake County, UT; 
Waukesha County, WI; and the aggregate of Lincoln, Pipestone, and 
Yellow Medicine Counties, MN and Brookings County, SD. This data 
collection is intended to begin with household enumeration and 
enrollment of women, proceed through pregnancy and birth, and continue 
with follow-up of children for up to 21 years. This application is for 
the first three years of data collection, which includes data 
collection through the visits at which some of the children will be 24 
months old. Details of data collections beyond this period will be 
addressed at the time of renewal or in future applications. Women who 
are pregnant will be eligible for participation if, at the time of 
household enumeration and screening, they are within the first 
trimester of pregnancy. Women who are not pregnant will be eligible if, 
at the time of household enumeration and screening, they are 18-49 
years of age, are neither surgically nor medically sterile, and can 
participate in the consent process. A subset of age-eligible women with 
a high likelihood of pregnancy (e.g., planning to become pregnant) will 
be enrolled to enable assessment of peri-conceptional

[[Page 65050]]

exposures, should they become pregnant. The remainder of the study 
population will comprise women enrolled early in pregnancy. The seven 
centers combined will follow approximately 1000 infants born to women 
enrolled in the first year of this Pilot Study. Infants born to women 
enrolled in this Pilot Study but born after the eligibility period for 
the Pilot will be eligible for enrollment in the full NCS. The schedule 
of participant contacts for this data collection includes home visits, 
clinic visits, and phone contacts, and is described in the NCS Research 
Plan: http://nationalchildrensstudy.gov. Home visits before and during 
pregnancy will include collection of interview data, environmental 
specimens such as air and dust samples, maternal and paternal 
biospecimens such as blood and hair samples, and a brief physical 
examination including anthropometric measures and blood pressure. 
During pregnancy, women will receive up to three fetal ultrasounds to 
assess fetal growth. At birth, cord blood and placental samples will be 
collected and the infant will receive a brief developmental assessment. 
During infancy, home visits will include collection of interview data, 
environmental specimens, biospecimens from the infant and parents, a 
brief physical examination of the infant, and assessment of infant 
development and parental-infant interactions. Burden statement: The 
public burden for this Study will vary depending on the eligibility and 
pregnancy status of potential participants at the time of household 
screening. Women who are not pregnant at the time of screening will 
have varying burden depending on their likelihood of pregnancy and, 
should they become pregnant, the time to pregnancy. The burden for 
women enrolled during pregnancy will depend on when during pregnancy 
they are identified and enrolled in the Study. The table provides an 
annualized average burden per person for each stage of the Pilot Study 
over the three year period of the Study.

    Estimated Average Annual Burden for Pilot Study for National Children's Study, Based on Three Year Totals
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                                                                Estimated
 Types of respondents (estimated hourly       Estimated         number of      Average  burden  Estimated  total
                  rate)                       number of       responses per       hours per      annual  burden
                                             respondents       respondent         response            hours
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Household activities ($12/hr):
    Household enumeration...............            76,911              0.33              0.08             2,051
    Eligibility screening...............            45,316              0.33              0.08             1,208
Preconception activities ($12/hr):
    High probability women..............             4,117              1.33              1.15             6,285
    Moderate prob, women................             5,500                 1              0.08               458
    Low probability women...............             3,578              0.33              0.08                95
    Pregnancy activities--women ($12/hr)               954                 7              0.62             4,134
    Birth activities--mothers & children               912                 2              0.38               684
     ($12/hr)...........................
    Postnatal activities--mothers &                    893                 4              0.81             2,887
     children ($12/hr)..................
    Fathers ($12/hr)....................               954                 2              0.72             1,370
    Health care providers ($90/hr)......               500              0.33              0.05                 8
    Community leaders ($75/hr)..........               500              0.33              0.05                 8
    Child care providers ($25/hr).......               364              0.33              1.00               121
        Total...........................          * 79,229  ................  ................           19,209
----------------------------------------------------------------------------------------------------------------
* Total number of respondents is less than the sum of the column since the mothers will be identified in the
  household enumeration and screening.

    The estimated annualized cost to respondents is $234,488 based on 
the differential hourly rate estimates in the above table. There are no 
Capital Costs to report. There are no Operating or Maintenance Costs to 
report.
    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 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.

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 Kenneth C. Schoendorf, MD, MPH, National Institute 
of Child Health and Human Development, Building 6100, 5C01, 6100 
Executive Blvd, Bethesda, Maryland, 20892, or call non-toll free number 
(301) 594-9147, or e-mail 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: November 6, 2007.
Paul Johnson,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-22597 Filed 11-16-07; 8:45 am]
BILLING CODE 4140-01-P