New Proposed Collection; Comment Request; Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study, 38670-38671 [2011-16612]
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38670
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
PhD, Project Officer, National Cancer
Institute, NIH, EPN 4095A, 6130
Executive Boulevard MSC 7335,
Bethesda, Maryland 20892–7335, or call
non-toll-free number 301–594–4410, or
Fax your request to 301–435–3710, or email your request, including your
address, to thompsof@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: June 27, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2011–16613 Filed 6–30–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Neuropsychosocial Measures
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. This proposed
information collection was previously
published in the Federal Register on
May 2, 2011, pages 24497–24498, and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
Proposed Collection
Title: Neuro-developmental and
Psycho-Social Measures Formative
Research 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 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 tools
to assess language, behavior, and
neurodevelopment, psychosocial stress,
and health literacy 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
OMB’s generic clearance to conduct
formative research featuring neurodevelopmental and psycho-social
measures.
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 neurodevelopmental and psycho-social
measures in a manner that minimizes
public information collection burden
compared to burden anticipated if these
projects were incorporated directly into
either the NCS Vanguard or Main Study.
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, infants, children,
fathers, community leaders, members,
and organizations, health care facilities
and professionals, public health,
environmental, social and cognitive
science professional organizations and
practitioners, hospital administrators,
cultural and faith-based centers, 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: $540,000 (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, ENVIRONMENTAL SCIENCE
Estimated
number of
respondents
Type of respondent
Adult Psychosocial Stress ................
mstockstill on DSK4VPTVN1PROD with NOTICES6
Data collection activity
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Members of NCS target population
(not NCS participants).
NCS participants ..............................
Child Developmental Measures ........
Health Disparities ..............................
Small, focused survey and instrument design and administration.
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Estimated
number of responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
2
1
8,000
E:\FR\FM\01JYN1.SGM
01JYN1
38671
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE—Continued
Data collection activity
Focus groups ....................................
Cognitive interviews ..........................
Total ...........................................
Estimated
number of responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
Health and Social Service Providers
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
4,000
2
1
8,000
2,000
2,000
2,000
2,000
1
1
1
1
1
1
1
1
2,000
2,000
2,000
2,000
2,000
2,000
500
500
1
1
1
1
1
1
2
2
2,000
2,000
1,000
1,000
...........................................................
45,000
........................
........................
54,000 hrs
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.
mstockstill on DSK4VPTVN1PROD with NOTICES6
Estimated
number of
respondents
Type of respondent
DATES: Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
DEPARTMENT OF HOMELAND
SECURITY
[FR Doc. 2011–16612 Filed 6–30–11; 8:45 am]
Qualification for an STCW
Endorsement as Officer in Charge of a
Navigational Watch (OICNW)
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Amended;
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, June
27, 2011, 8:30 a.m. to June 27, 2011, 6
p.m. The River Inn, 924 25th Street,
NW., Washington, DC 20037 which was
published in the Federal Register on
June 16, 2011, 76 FR 35223.
The meeting will be held July 15,
2011 at One Washington Circle Hotel,
One Washington Circle, NW.,
Washington, DC 20037. The meeting
time remains the same. The meeting is
closed to the public.
Dated: June 24, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–16615 Filed 6–30–11; 8:45 am]
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[Docket No. USCG–2011–0525]
Coast Guard, DHS.
Notice of availability.
AGENCY:
ACTION:
SUMMARY: The Coast Guard announces
the availability of Office of Vessel
Activities (CG–543) Policy Letter 11–07
amending its policy concerning
qualification for a STCW endorsement
as Officer in Charge of a Navigational
Watch (OICNW). The policy is currently
found in National Maritime Center
(NMC) Policy Letters 01–02 and 16–02.
DATES: This policy is effective on July 1,
2011.
This notice, as well as NMC Policy
Letters 01–02 and 16–02 and the new,
amended policy, are available in the
docket and can be viewed by going to
https://www.regulations.gov, inserting
USCG–2011–0525 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice,
call or e-mail Luke B. Harden, Mariner
Credentialing Program Policy Division
(CG–5434), U.S. Coast Guard; telephone
202–372–1206, e-mail
Luke.B.Harden@uscg.mil. If you have
questions on viewing material in the
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Manager, Docket Operations, telephone
202–366–9826.
SUPPLEMENTARY INFORMATION:
Background and Purpose
Title 46 Code of Federal Regulations
(CFR) section 11.903(c) establishes that
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01JYN1
Agencies
[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38670-38671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16612]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Neuropsychosocial
Measures 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. This proposed information collection was previously published
in the Federal Register on May 2, 2011, pages 24497-24498, and allowed
60 days for public comment. No comments were received. The purpose of
this notice is to allow an additional 30 days for public comment.
Proposed Collection
Title: Neuro-developmental and Psycho-Social Measures Formative
Research 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 tools to assess language, behavior, and
neurodevelopment, psychosocial stress, and health literacy 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 OMB's generic clearance to conduct formative research featuring
neuro-developmental and psycho-social measures.
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 neuro-developmental and psycho-social measures in a manner that
minimizes public information collection burden compared to burden
anticipated if these projects were incorporated directly into either
the NCS Vanguard or Main Study.
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, infants, children,
fathers, community leaders, members, and organizations, health care
facilities and professionals, public health, environmental, social and
cognitive science professional organizations and practitioners,
hospital administrators, cultural and faith-based centers, 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: $540,000 (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, Environmental Science
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Type of Estimated number of Average total annual
Data collection activity respondent number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Adult Psychosocial Stress..... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Child Developmental Measures.. NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Health Disparities............ NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Small, focused survey and NCS participants 4,000 2 1 8,000
instrument design and
administration.
[[Page 38671]]
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..................... ................ 45,000 .............. .............. 54,000 hrs
----------------------------------------------------------------------------------------------------------------
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.
DATES: Comments Due Date: Comments regarding this information
collection are best assured of having their full effect if received
within 30 days of the date of this publication.
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2011-16612 Filed 6-30-11; 8:45 am]
BILLING CODE 4140-01-P