National Institute of Child Health and Human Development; Submission for OMB Review; Comment Request; Stress and Cortisol Measurement Substudy for the National Children's Study, 30294-30297 [2012-12367]
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Federal Register / Vol. 77, No. 99 / Tuesday, May 22, 2012 / Notices
Consistent with the statute and
regulations, ACF requests extension of
the ACF–800.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Marianna Islands.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden
hours
per response
Total burden
hours
ACF–800 ..........................................................................................................
56
1
40
2,240
Center in Washington, DC to support a
Bill Emerson National Hunger Fellow.
Estimated Total Annual Burden
Hours: 2,240.
Additional Information
C.F.D.A. Number: 93.647.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–12302 Filed 5–21–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK4SPTVN1PROD with NOTICES
Administration for Children and
Families
Award of a Single Source Cooperative
Agreement Grant to the Congressional
Hunger Center in Washington, DC
Office of Policy, Research and
Evaluation, ACF, HHS.
ACTION: The Administration for Children
and Families (ACF) announces the
award of a single source cooperative
agreement to the Congressional Hunger
AGENCY:
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National Institutes of Health
Statutory Authority: The award is
authorized under Section 1110 of the Social
Security Act, 42 U.S.C. § 613.
The Administration for
Children and Families (ACF), Office of
the Assistant Secretary (OAS),
announces the award of a single source
cooperative agreement for $3,000 with
the Congressional Hunger Center (CHC)
in Washington, DC, to support a Bill
Emerson National Hunger Fellow who
will work on hunger and obesity issues
for young children. The Fellow will
work closely with the ACF health team
on strengthening its strategic vision to
improve health and nutrition in
children’s programs. The Fellow will
work with the team to examine
programs in the Office of Child Care
(OCC), OCC Tribal Maternal, Infant, and
Early Childhood Home Visiting
(TMIECHV) Grant Program under the
Affordable Care Act (ACA), and the
Office of Head Start, and will
communicate with other agencies on
child-focused nutrition programs. There
is currently no individual in ACF
designated to work specifically on these
nutrition- and hunger-related issues.
Additionally, the Fellow will work with
the ACF health team to synthesize ideas
emergent from this investigative work to
further develop strategies for integrating
hunger- and obesity-prevention
strategies into ACF’s childhood
programming.
DATES: March 1, 2012—February 28,
2013.
FOR FURTHER INFORMATION CONTACT:
George Askew, MD, FAAP, Senior
Policy Advisor, Office of the Assistant
Secretary, 901 D Street SW.,
Washington, DC 20447. Telephone:
202–401–1399; Email:
george.askew@acf.hhs.gov.
SUMMARY:
George Askew,
Senior Policy Advisor, Office of the Assistant
Secretary.
[FR Doc. 2012–12297 Filed 5–21–12; 8:45 am]
BILLING CODE 4184–07–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Child Health and
Human Development; Submission for
OMB Review; Comment Request;
Stress and Cortisol Measurement
Substudy for the National Children’s
Study
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 February 17,
2012, pages 9666–9668 (Volume 77,
Number 33) of the Federal Register and
allowed 60 days for public comment.
One comment was received. The
commenter questioned the value of the
National Children’s Study overall and
suggested that the NCS be eliminated.
The NCS is implemented to meet the
requirements of the Children’s Health
Act of 2000 (Pub. L. 106–310). 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: Stress and
Cortisol Measurement Substudy for the
National Children’s Study (NCS). Type
of Information Collection Request: New.
Need and Use of Information Collection:
The Children’s Health Act of 2000 (Pub.
L. 106–310) states:
SUMMARY:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
E:\FR\FM\22MYN1.SGM
22MYN1
30295
Federal Register / Vol. 77, No. 99 / Tuesday, May 22, 2012 / Notices
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) Plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) Investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) REQUIREMENT.—The study under
subsection (b) shall—
(1) Incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) Gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) Consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the Stress and
Cortisol Measurement Substudy will
develop an optimized, item-reduced
measure of self-reported stress that is
supported empirically through
convergent validity analysis of stress
biomarkers. Specifically, key
moderators of stress biomarkers will be
evaluated to inform the efficiency and
quality of measurements during
pregnancy. Development of a
scientifically robust maternal stress
measure would measure chronic stress
more efficiently, would not require
biospecimen collection and biomarker
analyses, and would thereby reduce
participant burden and NCS Vanguard
(Pilot) and NCS Main Study costs. With
this information collection request, the
NCS seeks to obtain OMB’s clearance to
conduct a substudy aimed at developing
a validated questionnaire that will
reflect specific biological and
physiological measures of maternal
stress.
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. By
studying children through their
different phases of growth and
development, researchers will be better
able to understand the role these factors
have on health and disease. 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 is led by a consortium
of federal partners: The U.S. Department
of Health and Human Services
(including the Eunice Kennedy Shriver
National Institute of Child Health and
Human Development and the National
Institute of Environmental Health
Sciences of the National Institutes of
Health and the Centers for Disease
Control and Prevention), and the U.S.
Environmental Protection Agency.
To conduct the detailed preparation
needed for a study of this size and
complexity, the NCS was designed to
include a preliminary pilot study
known as the Vanguard Study. The
purpose of the Vanguard Study is to
assess the feasibility, acceptability, and
cost of the recruitment strategy, study
procedures, and outcome assessments
that are to be used in the NCS Main
Study. The Vanguard Study begins prior
to the NCS Main Study and will run in
parallel with the Main Study. At every
phase of the NCS, the multiple
methodological studies conducted
during the Vanguard phase will inform
the implementation and analysis plan
for the Main Study.
In this information collection request,
the NCS requests approval from OMB to
perform a multi-center substudy, called
the Stress and Cortisol Measurement
Substudy. This substudy aims to
determine the most reliable, acceptable,
and cost-efficient approach for assessing
maternal stress. Maternal stress is of
particular interest to the NCS due to
studies that have shown an association
between maternal stress and negative
health outcomes, including preterm
birth which is one of the most important
problems in maternal-child health in the
U.S. Stress factors are also more
prevalent in the population of sociodemographically disadvantaged women
who are at an increased risk for preterm
birth. Maternal stress is associated with
additional health outcomes, such as
still-birth, low birth weight, problems in
offspring brain function and behavior
(including lower IQ and impaired
executive function), immune-related
problems such as allergies and asthma,
congenital malformations, infections,
and numerous disorders of organ
systems.
Development of a scientifically robust
and validated questionnaire to reflect
specific physiological measures of stress
would allow us to measure chronic
stress more efficiently, would not
require biospecimen collection and
biomarker analyses, and would thereby
reduce participant burden and Study
costs. To develop this instrument, the
NCS will collect several types of
information from substudy participants
through medical record abstraction,
questionnaires (a series of validated
stress measures), physiological
measures (heart rate and self-reported
stress), and several types of
biospecimens.
Frequency of Response: Annual [As
needed].
Affected Public: Pregnant women and
their children.
Type of Respondents: Pregnant
women who are not geographically
eligible to enroll in the NCS Vanguard
Study.
Annual reporting burden: See Table 1.
The annualized cost to respondents is
estimated at: $73,500 (based on $10 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN AND COST SUMMARY, STRESS AND CORTISOL MEASUREMENTS
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Data collection activity
Type of respondent
Screening ............................
Estimated
number of
respondents
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Saliva Self-Collection Demonstration.
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Estimated
number of
responses per
respondent
Average
burden hours
per response
(in hours)
Estimated
total annual
burden hours
Estimated
total annual
respondent
cost
2,100
1
5/60
175
$1,750
700
1
15/60
175
1,750
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Federal Register / Vol. 77, No. 99 / Tuesday, May 22, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN AND COST SUMMARY, STRESS AND CORTISOL MEASUREMENTS—
Continued
Data collection activity
Urine Self-Collection Instructions.
Ecological Momentary Assessment Training.
Visit 1 Stress Questionnaire
Adult Blood ..........................
Adult Urine ..........................
Adult Hair ............................
Adult Saliva .........................
Demographic and Health
Interview.
Participant Contact Information Sheet.
Take-Home Questionnaire ..
Time Diary ...........................
Heart Monitoring .................
Visit 2 Stress Questionnaire
Stressful Life Events Schedule Checklist.
srobinson on DSK4SPTVN1PROD with NOTICES
Total .............................
Type of respondent
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
Members of NCS target
population (not NCS participants).
.............................................
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 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
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Estimated
number of
respondents
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Estimated
number of
responses per
respondent
Frm 00037
Estimated
total annual
burden hours
Estimated
total annual
respondent
cost
700
1
5/60
58
583
700
1
30/60
350
3,500
700
1
60/60
700
7,000
700
2
30/60
700
7,000
700
1
15/60
175
1,750
700
2
15/60
350
3,500
700
28
3/60
980
9,800
700
1
60/60
700
7,000
700
1
5/60
58
583
700
1
30/60
350
3,500
700
72
2/60
1,680
16,800
700
1
2/60
23
233
700
1
45/60
525
5,250
700
1
30/60
350
3,500
2,100
........................
........................
7,350
73,500
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
OIRA_submission@omb.eop.gov, 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
PO 00000
Average
burden hours
per response
(in hours)
Fmt 4703
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Child Health and Human Development,
31 Center Drive Room 2A18, Bethesda,
Maryland 20892, or call a non-toll free
number (301) 496–1877 or Email your
request, including your address to
banksj@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.
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Federal Register / Vol. 77, No. 99 / Tuesday, May 22, 2012 / Notices
Dated: May 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. 2012–12367 Filed 5–21–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Closed
Meetings
srobinson on DSK4SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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/
contract proposals and the discussions
could disclose confidential trade secrets
or commercial property such as
patentable material, and personal
information concerning individuals
associated with the grant applications/
contract proposals the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Tools To
Probe DNA Repair and Damage Signaling
Networks.
Date: June 6, 2012.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6116
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: David G. Ransom, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Room 8133, Bethesda,
MD 20892–8328, 301–451–4757,
david.ransom@nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Cancer
Prevention Research Small Grant Program
(R03).
Date: June 28, 2012.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel
Conference & Center, 5701 Marinelli Road,
North Bethesda, MD.
Contact Person: Clifford W Schweinfest,
Ph.D., Scientific Review Officer, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
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Institute, NIH, 6116 Executive Blvd., Room
8050a, Bethesda, MD 20892–8329, 301–402–
9415, schweinfestcw@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 16, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–12387 Filed 5–21–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Amended;
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Neurotransporters,
Receptors, and Calcium Signaling Study
Section, June 7, 2012, 8:00 a.m. to June
7, 2012, 5:00 p.m., Embassy Suites at the
Chevy Chase Pavilion, 4300 Military
Road NW., Washington, DC, 20015
which was published in the Federal
Register on May 8, 2012, 77FR 27073–
27075.
The meeting will be held on June 7,
2012. The meeting location has been
changed to the Mayflower Renaissance
1127 Connecticut Ave. NW.,
Washington, DC 20036. The meeting is
closed to the public.
Dated: May 16, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–12363 Filed 5–21–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2012–0019]
Privacy Act of 1974; U.S. Customs and
Border Protection, DHS/CBP–006—
Automated Targeting System, System
of Records
AGENCY:
PO 00000
Privacy Office, DHS.
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ACTION:
30297
Notice of Privacy Act system of
records.
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security proposes to update
and expand an existing Department of
Homeland Security system of records
notice titled, U.S. Customs and Border
Protection, DHS/CBP–006—Automated
Targeting System (ATS) 72 FR 43650,
August 6, 2007. The Department of
Homeland Security (DHS) and U.S.
Customs and Border Protection (CBP)
have designed ATS to efficiently
perform risk assessments on information
pertaining to international travelers and
import and export shipments attempting
to enter or leave the United States. ATS
uses a rule-managed technology that
facilitates the targeting of high-risk
travelers and cargo.
DHS/CBP is publishing this System of
Records Notice (SORN) to update ATS
and to update and expand the categories
of individuals, categories of records,
routine uses, access provisions, and
sources of data stored in ATS.
Elsewhere in the Federal Register, the
Department of Homeland Security is
concurrently issuing a Notice of
Proposed Rulemaking exempting this
system of records from certain
provisions of the Privacy Act. This
updated and expanded system will be
included in the Department of
Homeland Security’s inventory of
record systems.
DATES: Submit comments on or before
June 21, 2012. This system will be
effective June 21, 2012.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2012–0019 by one of the following
methods:
• Federal e-Rulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 703–483–2999.
• Mail: Mary Ellen Callahan, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received go to https://
www.regulations.gov.
SUMMARY:
For
general questions please contact:
Laurence E. Castelli (202–325–0280),
CBP Privacy Officer, Office of
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Notices]
[Pages 30294-30297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development;
Submission for OMB Review; Comment Request; Stress and Cortisol
Measurement Substudy 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 February 17, 2012, pages 9666-9668 (Volume 77, Number 33)
of the Federal Register and allowed 60 days for public comment. One
comment was received. The commenter questioned the value of the
National Children's Study overall and suggested that the NCS be
eliminated. The NCS is implemented to meet the requirements of the
Children's Health Act of 2000 (Pub. L. 106-310). 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: Stress and Cortisol Measurement
Substudy for the National Children's Study (NCS). Type of Information
Collection Request: New. Need and Use of Information Collection: The
Children's Health Act of 2000 (Pub. L. 106-310) states:
(a) PURPOSE.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct
a national longitudinal study of environmental influences (including
[[Page 30295]]
physical, chemical, biological, and psychosocial) on children's
health and development.
(b) IN GENERAL.--The Director of the National Institute of Child
Health and Human Development* shall establish a consortium of
representatives from appropriate Federal agencies (including the
Centers for Disease Control and Prevention, the Environmental
Protection Agency) to--
(1) Plan, develop, and implement a prospective cohort study,
from birth to adulthood, to evaluate the effects of both chronic and
intermittent exposures on child health and human development; and
(2) Investigate basic mechanisms of developmental disorders and
environmental factors, both risk and protective, that influence
health and developmental processes.
(c) REQUIREMENT.--The study under subsection (b) shall--
(1) Incorporate behavioral, emotional, educational, and
contextual consequences to enable a complete assessment of the
physical, chemical, biological, and psychosocial environmental
influences on children's well-being;
(2) Gather data on environmental influences and outcomes on
diverse populations of children, which may include the consideration
of prenatal exposures; and
(3) Consider health disparities among children, which may
include the consideration of prenatal exposures.
To fulfill the requirements of the Children's Health Act, the
Stress and Cortisol Measurement Substudy will develop an optimized,
item-reduced measure of self-reported stress that is supported
empirically through convergent validity analysis of stress biomarkers.
Specifically, key moderators of stress biomarkers will be evaluated to
inform the efficiency and quality of measurements during pregnancy.
Development of a scientifically robust maternal stress measure would
measure chronic stress more efficiently, would not require biospecimen
collection and biomarker analyses, and would thereby reduce participant
burden and NCS Vanguard (Pilot) and NCS Main Study costs. With this
information collection request, the NCS seeks to obtain OMB's clearance
to conduct a substudy aimed at developing a validated questionnaire
that will reflect specific biological and physiological measures of
maternal stress.
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. By studying children through their different phases of growth
and development, researchers will be better able to understand the role
these factors have on health and disease. 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
is led by a consortium of federal partners: The U.S. Department of
Health and Human Services (including the Eunice Kennedy Shriver
National Institute of Child Health and Human Development and the
National Institute of Environmental Health Sciences of the National
Institutes of Health and the Centers for Disease Control and
Prevention), and the U.S. Environmental Protection Agency.
To conduct the detailed preparation needed for a study of this size
and complexity, the NCS was designed to include a preliminary pilot
study known as the Vanguard Study. The purpose of the Vanguard Study is
to assess the feasibility, acceptability, and cost of the recruitment
strategy, study procedures, and outcome assessments that are to be used
in the NCS Main Study. The Vanguard Study begins prior to the NCS Main
Study and will run in parallel with the Main Study. At every phase of
the NCS, the multiple methodological studies conducted during the
Vanguard phase will inform the implementation and analysis plan for the
Main Study.
In this information collection request, the NCS requests approval
from OMB to perform a multi-center substudy, called the Stress and
Cortisol Measurement Substudy. This substudy aims to determine the most
reliable, acceptable, and cost-efficient approach for assessing
maternal stress. Maternal stress is of particular interest to the NCS
due to studies that have shown an association between maternal stress
and negative health outcomes, including preterm birth which is one of
the most important problems in maternal-child health in the U.S. Stress
factors are also more prevalent in the population of socio-
demographically disadvantaged women who are at an increased risk for
preterm birth. Maternal stress is associated with additional health
outcomes, such as still-birth, low birth weight, problems in offspring
brain function and behavior (including lower IQ and impaired executive
function), immune-related problems such as allergies and asthma,
congenital malformations, infections, and numerous disorders of organ
systems.
Development of a scientifically robust and validated questionnaire
to reflect specific physiological measures of stress would allow us to
measure chronic stress more efficiently, would not require biospecimen
collection and biomarker analyses, and would thereby reduce participant
burden and Study costs. To develop this instrument, the NCS will
collect several types of information from substudy participants through
medical record abstraction, questionnaires (a series of validated
stress measures), physiological measures (heart rate and self-reported
stress), and several types of biospecimens.
Frequency of Response: Annual [As needed].
Affected Public: Pregnant women and their children.
Type of Respondents: Pregnant women who are not geographically
eligible to enroll in the NCS Vanguard Study.
Annual reporting burden: See Table 1. The annualized cost to
respondents is estimated at: $73,500 (based on $10 per hour). There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
Table 1--Estimated Annual Reporting Burden and Cost Summary, Stress and Cortisol Measurements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Average burden Estimated
Estimated number of hours per Estimated total annual
Data collection activity Type of respondent number of responses per response (in total annual respondent
respondents respondent hours) burden hours cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening................................. Members of NCS target 2,100 1 5/60 175 $1,750
population (not NCS
participants).
Saliva Self-Collection Demonstration...... Members of NCS target 700 1 15/60 175 1,750
population (not NCS
participants).
[[Page 30296]]
Urine Self-Collection Instructions........ Members of NCS target 700 1 5/60 58 583
population (not NCS
participants).
Ecological Momentary Assessment Training.. Members of NCS target 700 1 30/60 350 3,500
population (not NCS
participants).
Visit 1 Stress Questionnaire.............. Members of NCS target 700 1 60/60 700 7,000
population (not NCS
participants).
Adult Blood............................... Members of NCS target 700 2 30/60 700 7,000
population (not NCS
participants).
Adult Urine............................... Members of NCS target 700 1 15/60 175 1,750
population (not NCS
participants).
Adult Hair................................ Members of NCS target 700 2 15/60 350 3,500
population (not NCS
participants).
Adult Saliva.............................. Members of NCS target 700 28 3/60 980 9,800
population (not NCS
participants).
Demographic and Health Interview.......... Members of NCS target 700 1 60/60 700 7,000
population (not NCS
participants).
Participant Contact Information Sheet..... Members of NCS target 700 1 5/60 58 583
population (not NCS
participants).
Take-Home Questionnaire................... Members of NCS target 700 1 30/60 350 3,500
population (not NCS
participants).
Time Diary................................ Members of NCS target 700 72 2/60 1,680 16,800
population (not NCS
participants).
Heart Monitoring.......................... Members of NCS target 700 1 2/60 23 233
population (not NCS
participants).
Visit 2 Stress Questionnaire.............. Members of NCS target 700 1 45/60 525 5,250
population (not NCS
participants).
Stressful Life Events Schedule Checklist.. Members of NCS target 700 1 30/60 350 3,500
population (not NCS
participants).
-------------------------------------------------------------------------------
Total................................. ............................ 2,100 .............. .............. 7,350 73,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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 OIRA_submission@omb.eop.gov, 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, Maryland 20892, or call a non-toll free
number (301) 496-1877 or Email your request, including your address to
banksj@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.
[[Page 30297]]
Dated: May 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. 2012-12367 Filed 5-21-12; 8:45 am]
BILLING CODE 4140-01-P
