New Proposed Collection; Comment Request; Study Logistic Formative Research Methodology Studies for the National Children's Study, 23605-23606 [2011-10189]
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Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices
Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive Room 2A18, Bethesda,
Maryland, 20892, or call non-toll free
number (301) 496–1877 or E-mail your
request, including your address to
glavins@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: April 20, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communication, National
Institute of Child Health and Human
Development.
[FR Doc. 2011–10191 Filed 4–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Study Logistic Formative
Research Methodology Studies for the
National Children’s Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
SUMMARY:
Proposed Collection
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Title: Study Logistics Formative
Research Methodology Studies for the
National Children’s Study (NCS).
Type of Information Collection
Request: Generic Clearance.
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
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—
VerDate Mar<15>2010
15:36 Apr 26, 2011
Jkt 223001
(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 results of
formative research will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of new
and existing study measures, participant
communication techniques, and
technologies being utilized, and thereby
inform data collection methodologies
for the National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain an
OMB generic clearance to conduct
formative research relating to
instrument design and modality with a
view to reduce item and unit nonresponse to Study instruments while
preserving scientific quality.
The NCS has obtained an OMB
generic clearance to conduct survey and
instrument design and administration,
focus groups, cognitive interviews, and
health and social service provider
feedback information collection
surrounding outreach, recruitment and
retention (0925–0590; requesting
renewal). Under separate notice, the
NCS is also requesting an OMB generic
clearance to conduct formative research
featuring biospecimen and physical
measures, environmental, and
neurodevelopmental and psycho-social
information collection. These separate
and distinct generic clearances are
requested to facilitate the efficiency of
submission and review of these projects
as required by the OMB Office of
Information and Regulatory Affairs.
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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
23605
‘‘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 request, NCS is requesting
approval from OMB for formative
research activities relating to instrument
design and modality with a view to
reduce item and unit non-response to
Study instruments while preserving
scientific quality. The results from these
formative research projects will inform
the feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study instrument
design and modality in a manner that
minimizes public information collection
burden compared to burden anticipated
if these instruments were incorporated
directly into either the NCS Vanguard or
Main Study.
The NCS has obtained generic
clearance for formative research
activities pertaining to outreach,
recruitment and retention (0925–0590).
Under separate notice, the NCS also
requests an OMB generic clearance for
formative research featuring
biospecimen and physical measures,
environmental samples, and
E:\FR\FM\27APN1.SGM
27APN1
23606
Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices
neurodevelopmental measures. These
separate and distinct generic clearances
are requested to facilitate the efficiency
of submission and review of these
projects as required by the OMB Office
of Information and Regulatory Affairs.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis].
Affected Public: Members of the
public, researchers, practitioners, and
other health professionals.
Type of Respondents: Women of
child-bearing age, fathers, health care
facilities and professionals, public
health professional organizations and
practitioners, and schools and child care
organizations. These include both
persons enrolled in the NCS Vanguard
Study and their peers who are not
participating in the NCS Vanguard
Study.
Annual Reporting Burden: See Table
1. The annualized cost to respondents is
estimated at: $300,000 (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 SUMMARY, STUDY OPERATIONS
Estimated
number of responses per
respondent
Average burden hours per
response
Estimated total
annual burden
hours
requested
4,000
2
1
8,000
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
4,000
2
1
8,000
2,000
2,000
1
1
1
1
2,000
2,000
NCS participants ..............................
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
2,000
2,000
1
1
1
1
2,000
2,000
2,000
2,000
1
1
1
1
2,000
2,000
Cognitive interviews ..........................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
500
500
1
1
2
2
1,000
1,000
Total ...........................................
...........................................................
21,000
........................
........................
30,000
Estimated
number of
respondents
Data collection activity
Type of respondent
Small, focused survey and instrument design and administration.
NCS participants ..............................
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Focus groups ....................................
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.
FOR FURTHER INFORMATION CONTACT:
To request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Sarah L.
Glavin, Deputy Director, 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 non-toll free
number (301) 496–1877 or E-mail your
VerDate Mar<15>2010
15:36 Apr 26, 2011
Jkt 223001
request, including your address to
glavins@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: April 20, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
[FR Doc. 2011–10189 Filed 4–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; National Institutes
of Health Loan Repayment Programs
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Division of
Loan Repayment of the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
This proposed information collection
was previously published in the Federal
Register on February 10, 2011, at page
numbers 7570–7571 and allowed 60
days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The NIH
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: National
Institutes of Health Loan Repayment
Programs. Type of Information
Collection Request: Extension of a
currently approved collection (OMB No.
0925–0361, expiration date 06/30/11).
Form Numbers: NIH 2674–1, NIH 2674–
2, NIH 2674–3, NIH 2674–4, NIH 2674–
5, NIH 2674–6, NIH 2674–7, NIH 2674–
8, NIH 2674–9, NIH 2674–10, NIH
2674–11, NIH 2674–12, NIH 2674–13,
NIH 2674–14, NIH 2674–15, NIH 2674–
16, NIH 2674–17, NIH 2674–18, and
NIH 2674–19. Need and Use of
Information Collection: The NIH makes
available financial assistance, in the
form of educational loan repayment, to
M.D., PhD, Pharm.D., D.D.S., D.M.D.,
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23605-23606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10189]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Study Logistic
Formative Research Methodology Studies for the National Children's
Study
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Child
Health and Human Development (NICHD), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection
Title: Study Logistics Formative Research Methodology Studies for
the National Children's Study (NCS).
Type of Information Collection Request: Generic Clearance.
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
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
results of formative research will be used to maximize the efficiency
(measured by scientific robustness, participant and infrastructure
burden, and cost) of new and existing study measures, participant
communication techniques, and technologies being utilized, and thereby
inform data collection methodologies for the National Children's Study
(NCS) Vanguard and Main Studies. With this submission, the NCS seeks to
obtain an OMB generic clearance to conduct formative research relating
to instrument design and modality with a view to reduce item and unit
non-response to Study instruments while preserving scientific quality.
The NCS has obtained an OMB generic clearance to conduct survey and
instrument design and administration, focus groups, cognitive
interviews, and health and social service provider feedback information
collection surrounding outreach, recruitment and retention (0925-0590;
requesting renewal). Under separate notice, the NCS is also requesting
an OMB generic clearance to conduct formative research featuring
biospecimen and physical measures, environmental, and
neurodevelopmental and psycho-social information collection. These
separate and distinct generic clearances are requested to facilitate
the efficiency of submission and review of these projects as required
by the OMB Office of Information and Regulatory Affairs.
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 request, NCS is requesting approval from OMB for formative
research activities relating to instrument design and modality with a
view to reduce item and unit non-response to Study instruments while
preserving scientific quality. The results from these formative
research projects will inform the feasibility (scientific robustness),
acceptability (burden to participants and study logistics) and cost of
NCS Vanguard and Main Study instrument design and modality in a manner
that minimizes public information collection burden compared to burden
anticipated if these instruments were incorporated directly into either
the NCS Vanguard or Main Study.
The NCS has obtained generic clearance for formative research
activities pertaining to outreach, recruitment and retention (0925-
0590). Under separate notice, the NCS also requests an OMB generic
clearance for formative research featuring biospecimen and physical
measures, environmental samples, and
[[Page 23606]]
neurodevelopmental measures. These separate and distinct generic
clearances are requested to facilitate the efficiency of submission and
review of these projects as required by the OMB Office of Information
and Regulatory Affairs.
Frequency of Response: Annual [As needed on an on-going and
concurrent basis].
Affected Public: Members of the public, researchers, practitioners,
and other health professionals.
Type of Respondents: Women of child-bearing age, fathers, health
care facilities and professionals, public health professional
organizations and practitioners, and schools and child care
organizations. These include both persons enrolled in the NCS Vanguard
Study and their peers who are not participating in the NCS Vanguard
Study.
Annual Reporting Burden: See Table 1. The annualized cost to
respondents is estimated at: $300,000 (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 Summary, Study Operations
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Type of Estimated number of Average burden total annual
Data collection activity respondent number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Small, focused survey and NCS participants 4,000 2 1 8,000
instrument design and
administration.
Members of NCS 4,000 2 1 8,000
target
population (not
NCS
participants).
Health and 2,000 1 1 2,000
Social Service
Providers.
Community 2,000 1 1 2,000
Stakeholders.
----------------------------------------------------------------------------------------------------------------
Focus groups.................. NCS participants 2,000 1 1 2,000
Members of NCS 2,000 1 1 2,000
target
population (not
NCS
participants).
Health and 2,000 1 1 2,000
Social Service
Providers.
Community 2,000 1 1 2,000
Stakeholders.
----------------------------------------------------------------------------------------------------------------
Cognitive interviews.......... NCS participants 500 1 2 1,000
Members of NCS 500 1 2 1,000
target
population (not
NCS
participants).
---------------------------------------------------------------------------------
Total..................... ................ 21,000 .............. .............. 30,000
----------------------------------------------------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dr. Sarah L. Glavin, Deputy Director, 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 non-toll free number (301) 496-1877 or E-mail
your request, including your address to glavins@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: April 20, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2011-10189 Filed 4-26-11; 8:45 am]
BILLING CODE 4140-01-P
