The National Children's Study, Vanguard (Pilot) Study Proposed Collection; 60-day Comment Request, 52548-52551 [2013-20549]
Download as PDF
<![CDATA[
52548
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
20852, Telephone: (301) 443–5204,
Fax: (301) 443–9602, E-Mail:
Andrew.Diggs@ihs.gov.
3. Questions on systems matters may
be directed to:
Mr. Paul Gettys, Grant Systems
Coordinator, 801 Thompson Avenue,
TMP Suite 360, Rockville, MD 20852,
Phone: (301) 443–2114; or the DGM
main line (301) 443–5204, Fax: (301)
443–9602, E-Mail: Paul.Gettys@
ihs.gov.
VIII. Other Information
The Public Health Service strongly
encourages all cooperative agreement
and contract recipients to provide a
smoke-free workplace and promote the
non-use of all tobacco products. In
addition, Public Law 103–227, the ProChildren Act of 1994, prohibits smoking
in certain facilities (or in some cases,
any portion of the facility) in which
regular or routine education, library,
day care, health care, or early childhood
development services are provided to
children. This is consistent with the
HHS mission to protect and advance the
physical and mental health of the
American people.
Date: August 16, 2013.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2013–20535 Filed 8–22–13; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
The National Children’s Study,
Vanguard (Pilot) Study Proposed
Collection; 60-day Comment Request
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
Eunice Kennedy Shriver 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.
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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:28 Aug 22, 2013
Jkt 229001
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.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Ms. Sarah L. Glavin,
Deputy Director, Office of Science
Policy, Analysis and Communication,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of
Health, 31 Center Drive, Room 2A18,
Bethesda, Maryland 20892, or call a
non-toll free number (301) 496–7898 or
Email your request, including your
address to glavins@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
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.
Proposed Collection: The National
Children’s Study, Vanguard (Pilot)
Study, 0925–0593, Expiration 8/31/
2014—Revision, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of this request
is to continue data collection activities
for the NCS Vanguard Study and receive
a renewal of the Vanguard Study
clearance. The NCS also proposes the
initiation of a new enrollment cohort,
the addition of new Study visits,
revisions to existing Study visits, and
the initiation of methodological
substudies. The NCS Vanguard Study is
a prospective, longitudinal pilot study
of child health and development that
will inform the design of the Main
Study of the National Children’s Study.
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.
Findings from the Study will be made
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
available as the research progresses,
making potential benefits known to the
public as soon as possible. The National
Children’s Study (NCS) has several
components, including a pilot or
Vanguard Study, and a Main Study to
collect exposure and outcome data.
The NCS Vanguard Study continues
to follow the children and families
enrolled in the Vanguard Study,
conducting Study visits in participants’
homes and over the telephone. Data
Collection visits may include the
administration of questionnaires,
neurodevelopmental assessments,
physical measures, and the collection of
biospecimens and environmental
measures. The Vanguard Study has
yielded valuable data and field
experience related to participant
recruitment, the conduct of Study
assessments, and operational
requirements associated with NCS
infrastructure and field efforts. The
purpose of the proposed data collection
is to obtain further operational and
performance data on processes and
administration Study visit measures.
Research Questions: The primary
research goal is to systematically pilot
additional study visit measures and
collections for scientific robustness,
burden to participants and study
infrastructure, and cost for use in the
Vanguard (Pilot) Study and to inform
the Main Study. A secondary goal is to
increase enrollment in the Vanguard
Study through the identification of
subsequent pregnancies among enrolled
women.
Methods: The NCS Vanguard Study
data collection schedule includes prepregnancy, pregnancy, and birth
periods, as well as post-natal collection
points at defined intervals between 3
and 60 months. We propose to add or
modify the selected measures below to
address analytic goals of assessing
feasibility, acceptability, and cost of
specific study visit measures.
Enrollment of Sibling Birth Cohort:
We will enroll approximately 1,000
sibling births identified among currently
enrolled women. Following new
pregnancies will allow us to pilot the
collection of biospecimens,
environmental samples, and
standardized neurodevelopmental
assessments on sufficient numbers of
participants to understand what
activities are feasible in specific
settings, participants’ willingness to
complete requested measures, and
whether measures are useful and
scalable. Participants will be
administered the same protocol as
approved for the NCS Vanguard Study
by the Office of Information and
Regulatory Affairs within the Office of
E:\FR\FM\23AUN1.SGM
23AUN1
52549
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
Management and Budget, including the
collection of environmental samples,
biospecimens and physical
measurements during pre-pregnancy
and pre- and post-natal visits. Those
who report that they are trying to
conceive will be initially administered
the protocols approved for
preconception data collection. Others
who self-report a pregnancy at a later
time will receive pregnancy visit
instrumentation and collections.
Supplemental Information Collections
Core Questionnaire: We propose a
revised core questionnaire containing
key variables and designed to collect
core data at every study visit contact
from the time that the enrolled child is
6 months of age to the time the child is
5 years of age.
Age-Specific Modular Questionnaires:
At each Study visit, participants will be
administered brief questionnaire
modules that include measures relevant
to the specific age of the enrolled child.
Biospecimen Collections: Microbiome
swabs will be collected from NCS
children from the nasal cavity, inside of
the elbow, and rectum at two time
points. Shed deciduous teeth will be
collected from NCS children beginning
at age five. Instructions on retrieval and
shipment and to postage-paid shipping
materials will be provided to
participants. We propose to provide $10
per shed deciduous tooth collected and
shipped.
Environmental Sample Collection:
Noise measurements will be taken at the
homes of randomly-selected enrolled
participants. With their consent, their
homes will be equipped with a noise
meter and measured for noise levels at
various time intervals, and data
collectors will ask questions about the
source and frequency of noise they
encounter at home.
Physical Measures: BIA, or
bioelectrical impedance analysis, is a
non-invasive method for estimation of
body composition including Body Mass
Index. BIA will be measured on a small
subsample of approximately 200 NCS
children. For comparison, conventional
skinfold measurements using previously
approved and implemented protocols
will be collected. Physical activity in
children will be measured with
accelerometers at three data collection
points with a subsample of
approximately 600 NCS enrolled
children. Participants will be asked to
wear the Actigraph GT3X-plus physical
activity monitor on their wrist for a 7day period. Once the monitor has been
returned, a check for $25 will be mailed
to the participant as a token of
appreciation for their time. Pulmonary
function will be measured at age five
through spirometry, a simple, noninvasive method.
NIH Toolbox Measures: The NIH
Toolbox (www.nihtoolbox.org) is a series
of short assessments designed to
measure emotional, cognitive, sensory,
and motor function in children as young
as age three.
Assessing Participant Experience:
NCS participants will be asked to
complete self-administered
questionnaires designed to assess
feelings towards the NCS and
motivation to be engaged in research.
Through the use of these instruments,
the NCS aims to maintain positive
relationships with participants and
allow them to provide useful feedback
about the Study, its procedures and
perceived value to them, their families,
and communities.
Retrospective Pregnancy
Questionnaire: Women who joined the
NCS after the birth of the enrolled child
will be asked to complete a
Retrospective Pregnancy Questionnaire
designed to collect prenatal medical
information.
OMB approval is requested for 3
years. The additional annualized cost to
respondents over the 3 year data
collection period is estimated at an
annualized cost of $633,541 (based on
$10 per hour). The total estimated
annualized burden hours are 63,354
hours (see Table 1).
ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS THROUGH 60
MONTHS OF AGE OF THE CHILD
Data collection activity
Screening Activities:
Pregnancy Status Screener (Sibling
Birth Cohort) (9M to 60M).
Retrospective Pregnancy Screener
(Birth or 3M or 6M).
Continuous Activities:
Participant Verification, Scheduling, &
Tracing Interview (PVST) (PV1 to
60M).
tkelley on DSK3SPTVN1PROD with NOTICES
Parent-Caregiver Death Questionnaire
(3M to 60M).
Child Death Questionnaire (3M to 60M)
Participant Information Update SAQ—
Incentive Substudy (24M to 60M).
Validation Questionnaire (Pre-Pregnancy to 60M).
Non-Interview Respondent (NIR) SAQ
(Pre-Pregnancy to 60M).
Preconception Activities:
Pre-Pregnancy Interview .......................
Adult-Focused Biospecimen Collection—Blood & Urine.
Pregnancy Probability Group Follow-up
VerDate Mar<15>2010
17:28 Aug 22, 2013
Jkt 229001
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondent
Average
burden per
response
(in hrs)
Estimated total
annual burden
hours
Biological Mother ..................
1,072
10
3/60
536
Biological Mother ..................
422
1
39/60
274
Biological Mother, Primary
Caregiver, Secondary
Caregiver, Adult Caregiver-Identified Father.
Secondary Caregiver ............
843
15
9/60
1,898
3
1
2/60
0.17
Primary Caregiver .................
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
Biological Mother, Primary
Caregiver, Secondary
Caregiver, Adult Caregiver-Identified Father.
4
1,292
1
7
3/60
3/60
0.22
754
818
16
5/60
436
998
1
5/60
83
Biological Mother ..................
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
Biological Mother ..................
440
352
1
1
40/60
24/60
293
141
440
1
15/60
110
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
E:\FR\FM\23AUN1.SGM
23AUN1
52550
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS THROUGH 60
MONTHS OF AGE OF THE CHILD—Continued
Data collection activity
Prenatal Activities:
Pregnancy Visit 1 Interview ...................
Pregnancy Visit 2 Interview ...................
Adult-Focused Biospecimen Collection—Blood & Urine (PV1, PV2).
Environmental Sample Collection—Vacuum Bag Dust (PV1).
Father Pre-Natal Interview (PV1 or
PV2).
Pregnancy Health Care Log (PV1 or
PV2).
Pregnancy Loss, Stillbirth, & Neonatal
Death Interview.
Birth-Related Activities:
Birth Interview ........................................
Pregnancy Loss, Stillbirth, & Neonatal
Death Interview.
Adult-Focused Biospecimen Collection—Blood, Urine, Cord Blood,
Breast Milk, & Placenta.
Child-Focused Biospecimen Collection—Infant Blood Spot & Microbiome
Swab.
Postnatal Activities:
Infant Child Health Care Log (Birth to
60M).
3-Month Interview ..................................
Adult-Focused Biospecimen Collection—Breast Milk, Blood, Urine, &
Saliva (3M, 6M, 12M, 36M, 60M).
6-Month Interview ..................................
Core Questionnaire—Child, Adult Caregiver, & Household (6M to 60M, except 9M).
Child-Focused Biospecimen Collection—Urine,
Blood,
Saliva,
Microbiome Swab & Teeth (6M, 12M,
36M, 48M, 60M).
9-Month Interview ..................................
tkelley on DSK3SPTVN1PROD with NOTICES
Father/Father Figure Post-Natal Questionnaire (9M or 18M).
12-Month Interview ................................
Child-Focused Physical Measures—Anthropometry, Blood Pressure, Vision
Screening, Lung Function, & Motor
Skills (6M, 12M, 24M, 36M, 48M,
60M).
Environmental Sample Collection—Vacuum Bag Dust, Indoor and Outdoor
Visual Observations, & Dust Wipes
(12M, 36M, 48M, 60M).
18-Month Interview ................................
24-Month Interview ................................
30-Month Interview ................................
VerDate Mar<15>2010
17:28 Aug 22, 2013
Jkt 229001
Estimated
number of
respondents
Type of respondent
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
Biological Mother ..................
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
Primary Caregiver, Secondary Caregiver.
Adult-Caregiver Identified Father.
Biological Mother ..................
Estimated
number of
responses per
respondent
Average
burden per
response
(in hrs)
Estimated total
annual burden
hours
333
1
38/60
211
333
267
1
2
16/60
24/60
89
213
283
1
3/60
14
317
1
29/60
153
333
1
5/60
28
Biological Mother ..................
13
1
35/60
8
Primary Caregiver, Secondary Caregiver.
Biological Mother ..................
317
1
15/60
79
13
1
35/60
7
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
Child ......................................
Primary Caregiver, Secondary Caregiver.
253
1
34/60
144
253
253
1
1
3/60
20/60
13
84
Primary Caregiver, Secondary Caregiver.
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
2,050
1
5/60
171
475
1
39/60
309
807
11
43/60
6,364
475
1
38/60
301
1,064
10
30/60
5,320
Biological Mother, Primary
Caregiver, Secondary
Caregiver.
900
12
67/60
12,064
Primary Caregiver, Secondary Caregiver.
Adult-Caregiver Identified Father.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
554
1
5/60
46
558
1
17/60
158
554
1
45/60
416
952
15
63/60
14,989
Primary Caregiver, Secondary Caregiver.
1,046
14
15/60
3,660
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
562
1
47/60
440
1,046
1
30/60
523
1,009
1
59/60
992
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
E:\FR\FM\23AUN1.SGM
23AUN1
52551
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS THROUGH 60
MONTHS OF AGE OF THE CHILD—Continued
Data collection activity
36-Month Interview ................................
42-Month Interview ................................
48-Month Interview ................................
54-Month Interview ................................
60-Month Interview ................................
Subsample Studies:
Noise (36M, 60M) ..................................
Bioelectrical Impedance Analysis (BIA)
(48M, 60M).
Physical Activity (Accelerometer) (36M,
48M, 60M).
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondent
Average
burden per
response
(in hrs)
Estimated total
annual burden
hours
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
1,434
1
94/60
2,247
1,325
1
47/60
1,038
1,380
1
103/60
2,369
1,431
1
23/60
549
1,421
1
103/60
2,439
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
Primary Caregiver, Secondary Caregiver.
200
2
17/60
113
67
2
5/60
11
200
3
43/60
430
Total Vanguard (Pilot) Study ..........
...............................................
........................
........................
........................
60,519
Total Formative Research ..............
...............................................
2,835
........................
........................
2,835
Grand Total Vanguard (Pilot) Study
...............................................
29,166
........................
........................
63,354
Dated: August 14, 2013.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis, and Communications Eunice
Kennedy Shriver National Institute of Child
Health and Human Development National
Institutes of Health.
[FR Doc. 2013–20549 Filed 8–22–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Mental Health
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting 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
VerDate Mar<15>2010
17:28 Aug 22, 2013
Jkt 229001
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: September 19, 2013.
Open: 8:30 a.m. to 2:00 p.m.
Agenda: Presentation of NIMH Director’s
report and discussion of NIMH program and
policy issues.
Place: National Institutes of Health (NIH),
Neuroscience Center, 6001 Executive
Boulevard, Conference Room C/D/E,
Rockville, MD 20852.
Closed: 2:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Conference Room C/D/E,
Rockville, MD 20852.
Contact Person: Jane A. Steinberg, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–5047.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
PO 00000
Frm 00056
Fmt 4703
Sfmt 9990
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
In the interest of security, visitors will be
asked to show one form of identification (for
example, a government-issued photo ID,
driver’s license, or passport) and to state the
purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: August 16, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–20560 Filed 8–22–13; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Pages 52548-52551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20549]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
The National Children's Study, Vanguard (Pilot) Study Proposed
Collection; 60-day Comment Request
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 Eunice Kennedy Shriver
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.
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.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Ms. Sarah
L. Glavin, Deputy Director, Office of Science Policy, Analysis and
Communication, Eunice Kennedy Shriver National Institute of Child
Health and Human Development, National Institutes of Health, 31 Center
Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free
number (301) 496-7898 or Email your request, including your address to
glavins@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
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.
Proposed Collection: The National Children's Study, Vanguard
(Pilot) Study, 0925-0593, Expiration 8/31/2014--Revision, Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), National Institutes of Health (NIH).
Need and Use of Information Collection: The purpose of this request
is to continue data collection activities for the NCS Vanguard Study
and receive a renewal of the Vanguard Study clearance. The NCS also
proposes the initiation of a new enrollment cohort, the addition of new
Study visits, revisions to existing Study visits, and the initiation of
methodological substudies. The NCS Vanguard Study is a prospective,
longitudinal pilot study of child health and development that will
inform the design of the Main Study of the National Children's Study.
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. 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 (NCS) has several components,
including a pilot or Vanguard Study, and a Main Study to collect
exposure and outcome data.
The NCS Vanguard Study continues to follow the children and
families enrolled in the Vanguard Study, conducting Study visits in
participants' homes and over the telephone. Data Collection visits may
include the administration of questionnaires, neurodevelopmental
assessments, physical measures, and the collection of biospecimens and
environmental measures. The Vanguard Study has yielded valuable data
and field experience related to participant recruitment, the conduct of
Study assessments, and operational requirements associated with NCS
infrastructure and field efforts. The purpose of the proposed data
collection is to obtain further operational and performance data on
processes and administration Study visit measures.
Research Questions: The primary research goal is to systematically
pilot additional study visit measures and collections for scientific
robustness, burden to participants and study infrastructure, and cost
for use in the Vanguard (Pilot) Study and to inform the Main Study. A
secondary goal is to increase enrollment in the Vanguard Study through
the identification of subsequent pregnancies among enrolled women.
Methods: The NCS Vanguard Study data collection schedule includes
pre-pregnancy, pregnancy, and birth periods, as well as post-natal
collection points at defined intervals between 3 and 60 months. We
propose to add or modify the selected measures below to address
analytic goals of assessing feasibility, acceptability, and cost of
specific study visit measures.
Enrollment of Sibling Birth Cohort: We will enroll approximately
1,000 sibling births identified among currently enrolled women.
Following new pregnancies will allow us to pilot the collection of
biospecimens, environmental samples, and standardized
neurodevelopmental assessments on sufficient numbers of participants to
understand what activities are feasible in specific settings,
participants' willingness to complete requested measures, and whether
measures are useful and scalable. Participants will be administered the
same protocol as approved for the NCS Vanguard Study by the Office of
Information and Regulatory Affairs within the Office of
[[Page 52549]]
Management and Budget, including the collection of environmental
samples, biospecimens and physical measurements during pre-pregnancy
and pre- and post-natal visits. Those who report that they are trying
to conceive will be initially administered the protocols approved for
preconception data collection. Others who self-report a pregnancy at a
later time will receive pregnancy visit instrumentation and
collections.
Supplemental Information Collections
Core Questionnaire: We propose a revised core questionnaire
containing key variables and designed to collect core data at every
study visit contact from the time that the enrolled child is 6 months
of age to the time the child is 5 years of age.
Age-Specific Modular Questionnaires: At each Study visit,
participants will be administered brief questionnaire modules that
include measures relevant to the specific age of the enrolled child.
Biospecimen Collections: Microbiome swabs will be collected from
NCS children from the nasal cavity, inside of the elbow, and rectum at
two time points. Shed deciduous teeth will be collected from NCS
children beginning at age five. Instructions on retrieval and shipment
and to postage-paid shipping materials will be provided to
participants. We propose to provide $10 per shed deciduous tooth
collected and shipped.
Environmental Sample Collection: Noise measurements will be taken
at the homes of randomly-selected enrolled participants. With their
consent, their homes will be equipped with a noise meter and measured
for noise levels at various time intervals, and data collectors will
ask questions about the source and frequency of noise they encounter at
home.
Physical Measures: BIA, or bioelectrical impedance analysis, is a
non-invasive method for estimation of body composition including Body
Mass Index. BIA will be measured on a small subsample of approximately
200 NCS children. For comparison, conventional skinfold measurements
using previously approved and implemented protocols will be collected.
Physical activity in children will be measured with accelerometers at
three data collection points with a subsample of approximately 600 NCS
enrolled children. Participants will be asked to wear the Actigraph
GT3X-plus physical activity monitor on their wrist for a 7-day period.
Once the monitor has been returned, a check for $25 will be mailed to
the participant as a token of appreciation for their time. Pulmonary
function will be measured at age five through spirometry, a simple,
non-invasive method.
NIH Toolbox Measures: The NIH Toolbox (www.nihtoolbox.org) is a
series of short assessments designed to measure emotional, cognitive,
sensory, and motor function in children as young as age three.
Assessing Participant Experience: NCS participants will be asked to
complete self-administered questionnaires designed to assess feelings
towards the NCS and motivation to be engaged in research. Through the
use of these instruments, the NCS aims to maintain positive
relationships with participants and allow them to provide useful
feedback about the Study, its procedures and perceived value to them,
their families, and communities.
Retrospective Pregnancy Questionnaire: Women who joined the NCS
after the birth of the enrolled child will be asked to complete a
Retrospective Pregnancy Questionnaire designed to collect prenatal
medical information.
OMB approval is requested for 3 years. The additional annualized
cost to respondents over the 3 year data collection period is estimated
at an annualized cost of $633,541 (based on $10 per hour). The total
estimated annualized burden hours are 63,354 hours (see Table 1).
Estimated Annualized Burden Hours for Vanguard (Pilot) Study Respondents, Study Visits Through 60 Months of Age
of the Child
----------------------------------------------------------------------------------------------------------------
Estimated Average
Type of Estimated number of burden per Estimated
Data collection activity respondent number of responses per response (in total annual
respondents respondent hrs) burden hours
----------------------------------------------------------------------------------------------------------------
Screening Activities:
Pregnancy Status Screener Biological 1,072 10 3/60 536
(Sibling Birth Cohort) Mother.
(9M to 60M).
Retrospective Pregnancy Biological 422 1 39/60 274
Screener (Birth or 3M or Mother.
6M).
Continuous Activities:
Participant Verification, Biological 843 15 9/60 1,898
Scheduling, & Tracing Mother, Primary
Interview (PVST) (PV1 to Caregiver,
60M). Secondary
Caregiver,
Adult Caregiver-
Identified
Father.
Parent-Caregiver Death Secondary 3 1 2/60 0.17
Questionnaire (3M to 60M). Caregiver.
Child Death Questionnaire Primary 4 1 3/60 0.22
(3M to 60M). Caregiver.
Participant Information Primary 1,292 7 3/60 754
Update SAQ--Incentive Caregiver,
Substudy (24M to 60M). Secondary
Caregiver.
Validation Questionnaire Primary 818 16 5/60 436
(Pre-Pregnancy to 60M). Caregiver,
Secondary
Caregiver.
Non-Interview Respondent Biological 998 1 5/60 83
(NIR) SAQ (Pre-Pregnancy Mother, Primary
to 60M). Caregiver,
Secondary
Caregiver,
Adult Caregiver-
Identified
Father.
Preconception Activities:
Pre-Pregnancy Interview... Biological 440 1 40/60 293
Mother.
Adult-Focused Biospecimen Biological 352 1 24/60 141
Collection--Blood & Urine. Mother, Primary
Caregiver,
Secondary
Caregiver.
Pregnancy Probability Biological 440 1 15/60 110
Group Follow-up. Mother.
[[Page 52550]]
Prenatal Activities:
Pregnancy Visit 1 Biological 333 1 38/60 211
Interview. Mother, Primary
Caregiver,
Secondary
Caregiver.
Pregnancy Visit 2 Biological 333 1 16/60 89
Interview. Mother.
Adult-Focused Biospecimen Biological 267 2 24/60 213
Collection--Blood & Urine Mother, Primary
(PV1, PV2). Caregiver,
Secondary
Caregiver.
Environmental Sample Primary 283 1 3/60 14
Collection--Vacuum Bag Caregiver,
Dust (PV1). Secondary
Caregiver.
Father Pre-Natal Interview Adult-Caregiver 317 1 29/60 153
(PV1 or PV2). Identified
Father.
Pregnancy Health Care Log Biological 333 1 5/60 28
(PV1 or PV2). Mother.
Pregnancy Loss, Biological 13 1 35/60 8
Stillbirth, & Neonatal Mother.
Death Interview.
Birth-Related Activities:
Birth Interview........... Primary 317 1 15/60 79
Caregiver,
Secondary
Caregiver.
Pregnancy Loss, Biological 13 1 35/60 7
Stillbirth, & Neonatal Mother.
Death Interview.
Adult-Focused Biospecimen Biological 253 1 34/60 144
Collection--Blood, Urine, Mother, Primary
Cord Blood, Breast Milk, Caregiver,
& Placenta. Secondary
Caregiver.
Child........... 253 1 3/60 13
Child-Focused Biospecimen Primary 253 1 20/60 84
Collection--Infant Blood Caregiver,
Spot & Microbiome Swab. Secondary
Caregiver.
Postnatal Activities:
Infant Child Health Care Primary 2,050 1 5/60 171
Log (Birth to 60M). Caregiver,
Secondary
Caregiver.
3-Month Interview......... Biological 475 1 39/60 309
Mother, Primary
Caregiver,
Secondary
Caregiver.
Adult-Focused Biospecimen Biological 807 11 43/60 6,364
Collection--Breast Milk, Mother, Primary
Blood, Urine, & Saliva Caregiver,
(3M, 6M, 12M, 36M, 60M). Secondary
Caregiver.
6-Month Interview......... Primary 475 1 38/60 301
Caregiver,
Secondary
Caregiver.
Core Questionnaire--Child, Primary 1,064 10 30/60 5,320
Adult Caregiver, & Caregiver,
Household (6M to 60M, Secondary
except 9M). Caregiver.
Child-Focused Biospecimen Biological 900 12 67/60 12,064
Collection--Urine, Blood, Mother, Primary
Saliva, Microbiome Swab & Caregiver,
Teeth (6M, 12M, 36M, 48M, Secondary
60M). Caregiver.
9-Month Interview......... Primary 554 1 5/60 46
Caregiver,
Secondary
Caregiver.
Father/Father Figure Post- Adult-Caregiver 558 1 17/60 158
Natal Questionnaire (9M Identified
or 18M). Father.
12-Month Interview........ Primary 554 1 45/60 416
Caregiver,
Secondary
Caregiver.
Child-Focused Physical Primary 952 15 63/60 14,989
Measures--Anthropometry, Caregiver,
Blood Pressure, Vision Secondary
Screening, Lung Function, Caregiver.
& Motor Skills (6M, 12M,
24M, 36M, 48M, 60M).
Environmental Sample Primary 1,046 14 15/60 3,660
Collection--Vacuum Bag Caregiver,
Dust, Indoor and Outdoor Secondary
Visual Observations, & Caregiver.
Dust Wipes (12M, 36M,
48M, 60M).
18-Month Interview........ Primary 562 1 47/60 440
Caregiver,
Secondary
Caregiver.
24-Month Interview........ Primary 1,046 1 30/60 523
Caregiver,
Secondary
Caregiver.
30-Month Interview........ Primary 1,009 1 59/60 992
Caregiver,
Secondary
Caregiver.
[[Page 52551]]
36-Month Interview........ Primary 1,434 1 94/60 2,247
Caregiver,
Secondary
Caregiver.
42-Month Interview........ Primary 1,325 1 47/60 1,038
Caregiver,
Secondary
Caregiver.
48-Month Interview........ Primary 1,380 1 103/60 2,369
Caregiver,
Secondary
Caregiver.
54-Month Interview........ Primary 1,431 1 23/60 549
Caregiver,
Secondary
Caregiver.
60-Month Interview........ Primary 1,421 1 103/60 2,439
Caregiver,
Secondary
Caregiver.
Subsample Studies:
Noise (36M, 60M).......... Primary 200 2 17/60 113
Caregiver,
Secondary
Caregiver.
Bioelectrical Impedance Primary 67 2 5/60 11
Analysis (BIA) (48M, 60M). Caregiver,
Secondary
Caregiver.
Physical Activity Primary 200 3 43/60 430
(Accelerometer) (36M, Caregiver,
48M, 60M). Secondary
Caregiver.
---------------------------------------------------------------------------------
Total Vanguard (Pilot) ................ .............. .............. .............. 60,519
Study.
---------------------------------------------------------------------------------
Total Formative ................ 2,835 .............. .............. 2,835
Research.
---------------------------------------------------------------------------------
Grand Total Vanguard ................ 29,166 .............. .............. 63,354
(Pilot) Study.
----------------------------------------------------------------------------------------------------------------
Dated: August 14, 2013.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis, and Communications
Eunice Kennedy Shriver National Institute of Child Health and Human
Development National Institutes of Health.
[FR Doc. 2013-20549 Filed 8-22-13; 8:45 am]
BILLING CODE 4140-01-P
