National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Pilot Study for the National Children's Study, 65049-65050 [E7-22597]
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Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
65049
ANNUALIZED BURDEN TABLE
Type of
respondents
Estimated number
of respondents
Estimated number
of responses
per respondent
Average burden
per response
Estimated total
annual burden
hours requested
Asthma grantee survey ....................................................
1550
1
.25
387.5
Total ..........................................................................
................................
................................
................................
387.5
rwilkins on PROD1PC63 with NOTICES
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.
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 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: Jerry
Phelps, Division of Extramural Research
and Training, National Institute of
Environmental Health Sciences, P.O.
Box 12233, MD EC–21, 111 T.W.
Alexander Drive, RTP, NC 27709. Phone
(919) 541–4259. E-mail:
phelps@niehs.nih.gov.
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: November 7, 2007.
Marc Hollander,
NIEHS, Associate Director for Management.
[FR Doc. E7–22594 Filed 11–16–07; 8:45 am]
BILLING CODE 4140–01–P
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20:17 Nov 16, 2007
Jkt 214001
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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: https://
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
E:\FR\FM\19NON1.SGM
19NON1
65050
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices
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: https://
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
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Types of respondents (estimated hourly rate)
Household activities ($12/hr):
Household enumeration ...........................................................
Eligibility screening ...................................................................
Preconception activities ($12/hr):
High probability women ............................................................
Moderate prob, women ............................................................
Low probability women .............................................................
Pregnancy activities—women ($12/hr) .....................................
Birth activities—mothers & children ($12/hr) ............................
Postnatal activities—mothers & children ($12/hr) ....................
Fathers ($12/hr) ........................................................................
Health care providers ($90/hr) ..................................................
Community leaders ($75/hr) .....................................................
Child care providers ($25/hr) ....................................................
Total ...................................................................................
Average
burden
hours per
response
Estimated
total annual
burden hours
76,911
45,316
0.33
0.33
0.08
0.08
2,051
1,208
4,117
5,500
3,578
954
912
893
954
500
500
364
* 79,229
1.33
1
0.33
7
2
4
2
0.33
0.33
0.33
............................
1.15
0.08
0.08
0.62
0.38
0.81
0.72
0.05
0.05
1.00
............................
6,285
458
95
4,134
684
2,887
1,370
8
8
121
19,209
rwilkins on PROD1PC63 with NOTICES
* 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
VerDate Aug<31>2005
20:17 Nov 16, 2007
Jkt 214001
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
ncsinfo@mail.nih.gov.
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.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Establishment
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the Emerging
Neuroscience and Training Integrated
Review Group.
The Emerging Neuroscience and
Training Integrated Review Group shall
E:\FR\FM\19NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65049-65050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22597]
-----------------------------------------------------------------------
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: https://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: https://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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
ncsinfo@mail.nih.gov.
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
