National Institute of Child Health and Human Development Proposed Collection; Comment Request; Pilot Study for the National Children's Study, 5857-5858 [E8-1690]
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Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Notices
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondents (estimated hourly rate)
Average
burden hours
per response
Estimated total
annual burden
hours
Cognitive interviews ($10) ...............................................................................
150
1
3.0
450
Total ..........................................................................................................
3,150
........................
........................
5,825
Requests 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:
rwilkins on PROD1PC63 with NOTICES
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: Ruth A.
Brenner, 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 30 days of the date of
this publication.
Dated: January 23, 2008.
Paul Johnson,
NICHD Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E8–1688 Filed 1–30–08; 8:45 am]
BILLING CODE 4140–01–P
VerDate Aug<31>2005
18:07 Jan 30, 2008
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: 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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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:
https://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,
E:\FR\FM\31JAN1.SGM
31JAN1
5858
Federal Register / Vol. 73, No. 21 / Thursday, January 31, 2008 / Notices
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
number of
respondents
Types of respondents (estimated hourly rate)
Household activities ($12/hr):
Household enumeration .......................................................................
Eligibility screening ...............................................................................
Preconception activities ($12/hr):
High probability women—with pre-pregnancy visit ..............................
High probability women—without pre-pregnancy visit .........................
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) .......................................................................
Estimated
number of
responses per
respondent
Average burden
hours per
response
Estimated total
annual burden
hours
76,911
45,316
0.08
0.08
2,051
1,208
380
3737
5,500
3,578
954
912
893
954
500
500
364
1.7
0.67
1
0.33
7
2
4
2
0.33
0.33
0.33
0.93
0.08
0.08
0.08
0.62
0.38
0.81
0.72
0.05
0.05
1.00
1,730
199
458
95
4,134
684
2,887
1,370
8
8
121
*79,229
Total ......................................................................................................
0.33
0.33
..........................
..........................
14,953
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 $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:
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
ncsinfo@mail.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.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
VerDate Aug<31>2005
18:07 Jan 30, 2008
Jkt 214001
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Notices]
[Pages 5857-5858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1690]
-----------------------------------------------------------------------
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: https://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 ncsinfo@mail.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: 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
