The National Children's Study, Vanguard (Pilot) Study; Submission for OMB Review; 30-Day Comment Request, 76629-76632 [2013-30091]
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Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices
The Agencies have decided to continue
the program as currently designed for an
additional period of 2 years from the
date of publication of this notice.
DATES: This notice is effective December
18, 2013.
FOR FURTHER INFORMATION CONTACT: John
Burke, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5460, Silver Spring,
MD 20993–0002, 301–796–5738,
John.Burke@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 11, 2011 (76
FR 62808), the Agencies announced the
procedures and guiding principles for
the Parallel Review Pilot Program and
solicited nominations for the pilot. To
date, there has been significant interest
in the pilot and the Agencies are
currently working through the parallel
review process with the approved pilot
program participants. We believe that
interest in the pilot has also facilitated
mutually informative discussions
between additional sponsors and the
Agencies.
In the October 11, 2011 (76 FR 62808),
Parallel Review Pilot Program notice,
the Agencies stated their intent to
accept requests for a 2-year period,
followed by an announcement in the
Federal Register as to the future of the
pilot. The Agencies have decided to
continue the program as currently
designed for an additional 2 years from
the date of publication of this notice.
Once a representative group of
participants have completed the pilot
process the Agencies will formally
evaluate the program for best practices
and will announce any future revisions
and/or enhancements in a future
Federal Register notice.
Dated: December 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: December 6, 2013.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2013–29822 Filed 12–17–13; 8:45 am]
BILLING CODE 4120–01–M; 4160–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ehiers on DSK2VPTVN1PROD with NOTICES
National Institutes of Health
The National Children’s Study,
Vanguard (Pilot) Study; Submission for
OMB Review; 30-Day Comment
Request
In compliance with the
requirement of Section 3506(c)(2)(A) of
SUMMARY:
VerDate Mar<15>2010
15:27 Dec 17, 2013
Jkt 232001
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) 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 August 23,
2013, page 52548 and allowed 60-days
for public comment. Two public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The Eunice
Kennedy Shriver, National Institute of
Child Health and Human Development
(NICHD), 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: Desk Officer for NIH.
Comment 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.
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. 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.
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
FOR FURTHER INFORMATION CONTACT:
PO 00000
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76629
(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 currently
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Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices
includes pre-pregnancy, pregnancy, and
birth periods, as well as post-natal
collection points at defined intervals
between 3 and 30 months. This request
extends the collection of data about the
children in the Vanguard cohort through
60 months of age, with home visits
scheduled for children 36, 48, and 60
months of age. Two intervening remote
(phone or internet) survey data
collections are proposed as well. 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
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 the
biological mother at birth from the
vagina, mouth, and rectum and at 6, 24,
and 48- month visits from the nasal
cavity, mouth, and rectum. Microbiome
swabs will also be collected from NCS
children from the nasal cavity, mouth,
and rectum at 6, 24, and 48-month
visits. 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.
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. 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).
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS
THROUGH 60 MONTHS OF AGE OF THE CHILD
ehiers on DSK2VPTVN1PROD with NOTICES
Data collection activity
Estimated
number of
respondents
Type of respondent
Pregnancy Screening Activities:
Pregnancy Screener Sibling Biological Mother .............................
Birth Cohort SAQ (9M to 60M).
Retrospective Pregnancy Inter- Biological Mother .............................
view (Birth, 3M, 6M).
Continuous Activities:
Participant Verification & Tracing Pregnant Woman, Father/Father
(PVT) Interview (PV1 to 60M).
Figure, Biological Mother, Primary
Caregiver, Secondary Residence
Caregiver.
Validation Interview (Pre-Preg- Pregnant Woman, Father/Father
nancy to 60M).
Figure, Biological Mother, Primary
Caregiver, Secondary Residence
Caregiver.
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Estimated
number of
responses per
respondent
Average
burden per
response
(in hrs)
Estimated total
annual burden
hours
1,122
10
3/60
561
422
1
47/60
331
877
15
7/60
1,535
850
1
2/60
28
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Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS
THROUGH 60 MONTHS OF AGE OF THE CHILD—Continued
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Average
burden per
response
(in hrs)
Estimated total
annual burden
hours
Data collection activity
Type of respondent
Participant Information Update—
Incentive Substudy (24M to
60M).
Event Driven Activities:
Pregnancy Loss, Stillbirth, &
Neonatal
Death
Interview
(PV1, PV2, Birth).
Parent-Caregiver Death Interview (3M to 60M).
Child Death Interview (3M to
60M).
Non-Interview Respondent Interview (Pre-Pregnancy to 60M).
Primary Caregiver ............................
1,364
1
5/60
114
Pregnant Woman, Biological Mother
13
1
17/60
4
Proxy ................................................
3
1
3/60
0.17
Primary Caregiver ............................
4
1
3/60
0.22
Pre-Pregnant Woman, Pregnant
Woman, Father/Father Figure, Biological Mother, Primary Caregiver.
Secondary Residence Caregiver .....
603
1
5/60
50
221
1
13/60
48
Pre-Pregnant Woman ......................
Pre-Pregnant Woman ......................
445
356
1
1
21/60
26/60
156
154
Pre-Pregnant Woman ......................
445
1
15/60
111
Pregnant Woman .............................
Pregnant Woman .............................
Pregnant Woman .............................
333
333
267
1
1
2
50/60
18/60
26/60
278
100
231
Primary Caregiver ............................
283
1
3/60
14
Father/Father Figure ........................
317
1
32/60
169
Biological Mother .............................
333
1
5/60
28
Biological Mother .............................
Biological Mother .............................
317
253
1
1
15/60
85/60
79
358
Child .................................................
253
1
3/60
13
Primary Caregiver ............................
2,067
1
5/60
172
Primary Caregiver ............................
Biological Mother .............................
Primary Caregiver ............................
475
475
832
1
1
14
37/60
2/60
40/60
293
16
7,811
Primary Caregiver ............................
Primary Caregiver ............................
475
1,107
1
9
32/60
34/60
253
5,646
Primary Caregiver ............................
886
14
44/60
9,027
Primary Caregiver ............................
Father/Father Figure ........................
554
558
1
1
3/60
14/60
28
130
Primary Caregiver ............................
554
1
34/60
314
ehiers on DSK2VPTVN1PROD with NOTICES
Secondary Residence Interview
(36M, 48M, 60M).
Preconception Activities:
Pre-Pregnancy Interview ............
Adult-Focused Biospecimen Collection—Blood & Urine.
Pregnancy Probability Group
Follow-up.
Pre-Natal 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).
Birth Activities:
Birth Interview ............................
Adult-Focused Biospecimen Collection—Blood, Urine, Cord
Blood, Breast Milk, Placenta,
& Microbiome Swab.
Child-Focused Biospecimen Collection—Infant Blood Spot.
Post-Natal Activities:
Infant & Child Health Care Log
(Birth to 60M).
3-Month Interview ......................
Adult-Focused Biospecimen Collection—Breast Milk, Blood,
Urine, Saliva, & Microbiome
Swab (3M, 6M, 12M, 24M,
36M, 48M, 60M).
6-Month Interview ......................
Core
Questionnaire—Child,
Adult, & Household (6M to
60M, except 9M).
Child-Focused Biospecimen Collection—Urine, Blood, Saliva,
Microbiome Swab, & Teeth
(6M, 12M, 24M, 36M, 48M,
60M).
9-Month Interview ......................
Father Post-Natal Interview (9M
or 18M).
12-Month Interview ....................
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Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS
THROUGH 60 MONTHS OF AGE OF THE CHILD—Continued
Data collection activity
Estimated
number of
respondents
Type of respondent
Child-Focused Physical Measures—Anthropometry, Blood
Pressure, Vision Screening,
Lung Function, & Motor Skills
(6M, 12M, 24M, 36M, 48M,
60M).
Estimated
number of
responses per
respondent
Average
burden per
response
(in hrs)
Estimated total
annual burden
hours
Child .................................................
1,217
2
9/60
365
Primary Caregiver ............................
Primary Caregiver ............................
935
1,085
13
13
41/60
8/60
8,375
1,775
Primary Caregiver ............................
Primary Caregiver ............................
Primary Caregiver ............................
Primary Caregiver ............................
Child .................................................
Primary Caregiver ............................
Biological Mother, Biological Father
Primary Caregiver ............................
Primary Caregiver ............................
Primary Caregiver ............................
Child .................................................
562
1,046
1,286
1,711
1,711
1,364
1,364
1,380
1,431
1,332
1,332
1
1
1
1
1
1
1
1
1
1
1
40/60
26/60
50/60
61/60
22/60
32/60
15/60
89/60
23/60
46/60
22/60
375
453
1,072
1,740
627
728
341
2,047\
549
1,021
488
Primary Caregiver ............................
Primary Caregiver ............................
200
67
2
2
17/60
7/60
113
16
Primary Caregiver ............................
200
3
43/60
430
Total Vanguard (Pilot) Study
..........................................................
........................
........................
........................
48,567
Total Formative Research ..
..........................................................
........................
........................
........................
2,835
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 ....................
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).
Dated: December 6, 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. 2013–30091 Filed 12–17–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ehiers on DSK2VPTVN1PROD with NOTICES
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
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 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
the discussions could disclose
VerDate Mar<15>2010
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Jkt 232001
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 Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Low-Dose CT
Imaging (UO1).
Date: February 26, 2014.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, DEM
II, Suite 951, 6707 Democracy Boulevard,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: John K. Hayes, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Suite 959,
Bethesda, MD 20892, 301–451–3398, hayesj@
mail.nih.gov.
Dated: December 12, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–30012 Filed 12–17–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings 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 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
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]]>Agencies
[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76629-76632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30091]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
The National Children's Study, Vanguard (Pilot) Study; Submission
for OMB Review; 30-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) 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 August
23, 2013, page 52548 and allowed 60-days for public comment. Two public
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The Eunice Kennedy Shriver,
National Institute of Child Health and Human Development (NICHD),
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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH.
Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Dr. 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.
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 currently
[[Page 76630]]
includes pre-pregnancy, pregnancy, and birth periods, as well as post-
natal collection points at defined intervals between 3 and 30 months.
This request extends the collection of data about the children in the
Vanguard cohort through 60 months of age, with home visits scheduled
for children 36, 48, and 60 months of age. Two intervening remote
(phone or internet) survey data collections are proposed as well. 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 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
the biological mother at birth from the vagina, mouth, and rectum and
at 6, 24, and 48- month visits from the nasal cavity, mouth, and
rectum. Microbiome swabs will also be collected from NCS children from
the nasal cavity, mouth, and rectum at 6, 24, and 48-month visits. 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.
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.
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).
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
----------------------------------------------------------------------------------------------------------------
Pregnancy Screening
Activities:
Pregnancy Screener Sibling Biological 1,122 10 3/60 561
Birth Cohort SAQ (9M to Mother.
60M).
Retrospective Pregnancy Biological 422 1 47/60 331
Interview (Birth, 3M, 6M). Mother.
Continuous Activities:
Participant Verification & Pregnant Woman, 877 15 7/60 1,535
Tracing (PVT) Interview Father/Father
(PV1 to 60M). Figure,
Biological
Mother, Primary
Caregiver,
Secondary
Residence
Caregiver.
Validation Interview (Pre- Pregnant Woman, 850 1 2/60 28
Pregnancy to 60M). Father/Father
Figure,
Biological
Mother, Primary
Caregiver,
Secondary
Residence
Caregiver.
[[Page 76631]]
Participant Information Primary 1,364 1 5/60 114
Update--Incentive Caregiver.
Substudy (24M to 60M).
Event Driven Activities:
Pregnancy Loss, Pregnant Woman, 13 1 17/60 4
Stillbirth, & Neonatal Biological
Death Interview (PV1, Mother.
PV2, Birth).
Parent-Caregiver Death Proxy........... 3 1 3/60 0.17
Interview (3M to 60M).
Child Death Interview (3M Primary 4 1 3/60 0.22
to 60M). Caregiver.
Non-Interview Respondent Pre-Pregnant 603 1 5/60 50
Interview (Pre-Pregnancy Woman, Pregnant
to 60M). Woman, Father/
Father Figure,
Biological
Mother, Primary
Caregiver.
Secondary Residence Secondary 221 1 13/60 48
Interview (36M, 48M, 60M). Residence
Caregiver.
Preconception Activities:
Pre-Pregnancy Interview... Pre-Pregnant 445 1 21/60 156
Woman.
Adult-Focused Biospecimen Pre-Pregnant 356 1 26/60 154
Collection--Blood & Urine. Woman.
Pregnancy Probability Pre-Pregnant 445 1 15/60 111
Group Follow-up. Woman.
Pre-Natal Activities:
Pregnancy Visit 1 Pregnant Woman.. 333 1 50/60 278
Interview.
Pregnancy Visit 2 Pregnant Woman.. 333 1 18/60 100
Interview.
Adult-Focused Biospecimen Pregnant Woman.. 267 2 26/60 231
Collection--Blood & Urine
(PV1, PV2).
Environmental Sample Primary 283 1 3/60 14
Collection--Vacuum Bag Caregiver.
Dust (PV1).
Father Pre-Natal Interview Father/Father 317 1 32/60 169
(PV1 or PV2). Figure.
Pregnancy Health Care Log Biological 333 1 5/60 28
(PV1 or PV2). Mother.
Birth Activities:
Birth Interview........... Biological 317 1 15/60 79
Mother.
Adult-Focused Biospecimen Biological 253 1 85/60 358
Collection--Blood, Urine, Mother.
Cord Blood, Breast Milk,
Placenta, & Microbiome
Swab.
Child-Focused Biospecimen Child........... 253 1 3/60 13
Collection--Infant Blood
Spot.
Post-Natal Activities:
Infant & Child Health Care Primary 2,067 1 5/60 172
Log (Birth to 60M). Caregiver.
3-Month Interview......... Primary 475 1 37/60 293
Caregiver.
Biological 475 1 2/60 16
Mother.
Adult-Focused Biospecimen Primary 832 14 40/60 7,811
Collection--Breast Milk, Caregiver.
Blood, Urine, Saliva, &
Microbiome Swab (3M, 6M,
12M, 24M, 36M, 48M, 60M).
6-Month Interview......... Primary 475 1 32/60 253
Caregiver.
Core Questionnaire--Child, Primary 1,107 9 34/60 5,646
Adult, & Household (6M to Caregiver.
60M, except 9M).
Child-Focused Biospecimen Primary 886 14 44/60 9,027
Collection--Urine, Blood, Caregiver.
Saliva, Microbiome Swab,
& Teeth (6M, 12M, 24M,
36M, 48M, 60M).
9-Month Interview......... Primary 554 1 3/60 28
Caregiver.
Father Post-Natal Father/Father 558 1 14/60 130
Interview (9M or 18M). Figure.
12-Month Interview........ Primary 554 1 34/60 314
Caregiver.
[[Page 76632]]
Child-Focused Physical Child........... 1,217 2 9/60 365
Measures--Anthropometry,
Blood Pressure, Vision
Screening, Lung Function,
& Motor Skills (6M, 12M,
24M, 36M, 48M, 60M).
Primary 935 13 41/60 8,375
Caregiver.
Environmental Sample Primary 1,085 13 8/60 1,775
Collection--Vacuum Bag Caregiver.
Dust, Indoor and Outdoor
Visual Observations, &
Dust Wipes (12M, 36M,
48M, 60M).
18-Month Interview........ Primary 562 1 40/60 375
Caregiver.
24-Month Interview........ Primary 1,046 1 26/60 453
Caregiver.
30-Month Interview........ Primary 1,286 1 50/60 1,072
Caregiver.
36-Month Interview........ Primary 1,711 1 61/60 1,740
Caregiver.
Child........... 1,711 1 22/60 627
42-Month Interview........ Primary 1,364 1 32/60 728
Caregiver.
Biological 1,364 1 15/60 341
Mother,
Biological
Father.
48-Month Interview........ Primary 1,380 1 89/60 2,047\
Caregiver.
54-Month Interview........ Primary 1,431 1 23/60 549
Caregiver.
60-Month Interview........ Primary 1,332 1 46/60 1,021
Caregiver.
Child........... 1,332 1 22/60 488
Subsample Studies:
Noise (36M, 60M).......... Primary 200 2 17/60 113
Caregiver.
Bioelectrical Impedance Primary 67 2 7/60 16
Analysis (BIA) (48M, 60M). Caregiver.
Physical Activity Primary 200 3 43/60 430
(Accelerometer) (36M, Caregiver.
48M, 60M).
---------------------------------------------------------------
Total Vanguard (Pilot) ................ .............. .............. .............. 48,567
Study.
---------------------------------------------------------------
Total Formative ................ .............. .............. .............. 2,835
Research.
----------------------------------------------------------------------------------------------------------------
Dated: December 6, 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. 2013-30091 Filed 12-17-13; 8:45 am]
BILLING CODE 4140-01-P
