[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Notices]
[Pages 5857-5858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1690]


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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: 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 November 19, 2007, pages 65049-65050, and allowed 60 days 
for public comment. One comment was received questioning the utility of 
the proposed data collection. 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: 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 seven (7) National Children's Study Vanguard 
sites. 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, a long-term cohort study of 
environmental influences on child health and development authorized 
under the Children's Health Act of 2000. 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. Further details pertaining to the NCS 
background and planning, including the NCS Research Plan, can be found 
at: http://nationalchildrensstudy.gov. The Pilot Study 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 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. 
Home visits before and during pregnancy will include collection of 
interview data,

[[Page 5858]]

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 receive 
their first home visit during pregnancy will have a lower burden than 
those who receive their first visit before pregnancy. And, women who 
are not pregnant at the time of screening will have varying burden 
depending on their likelihood of pregnancy. 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
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                     Estimated       number of    Average burden     Estimated
  Types of respondents (estimated hourly rate)       number of     responses per     hours per     total annual
                                                    respondents     respondent       response      burden hours
----------------------------------------------------------------------------------------------------------------
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--with pre-pregnancy               380            1.7             0.93           1,730
     visit......................................
    High probability women--without pre-                    3737            0.67            0.08             199
     pregnancy visit............................
    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 ($12/hr)...             912            2               0.38             684
Postnatal activities--mothers & children ($12/               893            4               0.81           2,887
 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  ..............  ..............         14,953
----------------------------------------------------------------------------------------------------------------
* 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 $182,137 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: 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 the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. 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 the 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 30 days 
of the date of this publication.

    Dated: January 23, 2008.
Paul Johnson,
NICHD Project Clearance Liaison, National Institutes of Health.
[FR Doc. E8-1690 Filed 1-30-08; 8:45 am]
BILLING CODE 4140-01-P