National Institute of Child Health and Human Development Submission for OMB Review; Comment Request; New Proposed Collection, Neuropsychosocial Formative Research Methodological Studies for the National Children's Study, 19022-19023 [2012-7589]
Download as PDF
<![CDATA[
19022
Federal Register / Vol. 77, No. 61 / Thursday, March 29, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development Submission for
OMB Review; Comment Request; New
Proposed Collection,
Neuropsychosocial Formative
Research Methodological Studies for
the National Children’s Study
Under the provisions of
Section (3507(a)(1)(D)) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
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. Two written comments and
two verbal comments were received.
The verbal comments expressed support
for the broad scope of the study. The
written comments were identical and
questioned the cost and utility of the
study. The purpose of this notice is to
allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title:
Neuropsychosocial Formative Research
Methodological Studies for the National
Children’s Study (NCS). Type of
Information Request: NEW. Need and
Use of Information Collection: The
Children’s Health Act of 2000 (Pub. L.
106–310) states:
SUMMARY:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
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 of 2000, 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 (Pilot)
and Main Studies. With this information
collection request, the NCS seeks to
obtain OMB’s generic clearance to
conduct formative research featuring
neuropsychosocial 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 (Pilot) Study and Main Study
neuropsychosocial 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/potential NCS
participants, infants, children, fathers,
legal guardians, health care facilities
and professionals, hospital
administrators and staff, pediatric
professional organizations and
practitioners, educational professionals,
public health organizations, community
leaders, members, and organizations,
and cultural and faith-based centers.
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: $742,000 (based on
approximately $10 per hour for NCS
participants and members of the NCS
target population (non-NCS
participants), $101 per hour for health
providers (OB/GYNs), and $20 per hour
for social service providers). There are
no capital costs to report. There are no
operating or maintenance costs to
report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, NEUROPSYCHOSOCIAL MEASURES
Estimated
number of
respondents
Data collection activity
Type of respondent
Physical measurement and examinations.
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 ..............................
Members of NCS target population
(not NCS participants).
Health Care Providers ......................
Social Service Providers ..................
mstockstill on DSK4VPTVN1PROD with NOTICES
Child Developmental Measures (cognitive).
Computer-based reaction time testing.
Small, focused survey and instrument design and administration.
VerDate Mar<15>2010
17:14 Mar 28, 2012
Jkt 226001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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
4,000
2
2
1
1
8,000
8,000
1,000
1,000
1
1
1
1
1,000
1,000
E:\FR\FM\29MRN1.SGM
29MRN1
19023
Federal Register / Vol. 77, No. 61 / Thursday, March 29, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, NEUROPSYCHOSOCIAL MEASURES—Continued
Data collection activity
Focus groups ....................................
Cognitive interviews ..........................
mstockstill on DSK4VPTVN1PROD with NOTICES
Total ...........................................
18:06 Mar 28, 2012
Average
burden
hours per
response
Estimated
total annual
burden hours
requested
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
Health Care Providers ......................
Social Service Providers ..................
Community Stakeholders .................
NCS participants ..............................
Members of NCS target population
(not NCS participants).
2,000
2,000
2,000
1
1
1
1
1
1
2,000
2,000
2,000
1,000
1,000
2,000
500
500
1
1
1
1
1
1
1
1
2
2
1,000
1,000
2,000
1,000
1,000
...........................................................
45,000
........................
........................
54,000
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 enhance
the quality, utility, and clarity of the
information 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to Office of
Management and Budget, Office of
Information and Regulatory Affairs,
Attn: NIH Desk Officer, by Email to
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Ms.
Jamelle E. Banks, Public Health Analyst,
Office of Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive Room 2A18, Bethesda,
Maryland 20892, or call a non-toll free
number (301) 496–1877 or Email your
request, including your address to
banksj@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
VerDate Mar<15>2010
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondent
Jkt 226001
received within 30 days of the date of
this publication.
Dated: March 21, 2012.
Jamelle E. Banks,
Public Health Analyst, Office of Science
Policy, Analysis and Communications,
National Institute of Child Health and Human
Development.
[FR Doc. 2012–7589 Filed 3–28–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
MSC 7850, Bethesda, MD 20892, 301–435–
1235, geoffreys@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 20, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–7579 Filed 3–28–12; 8:45 am]
Center for Scientific Review; Notice of
Closed Meeting
BILLING CODE 4140–01–P
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
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Channels—
Physiology and Signaling.
Date: April 11, 2012.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Geoffrey G Schofield,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040–A,
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodegeneration.
Date: April 13, 2012.
Time: 12 p.m. to 2 p.m.
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 77, Number 61 (Thursday, March 29, 2012)]
[Notices]
[Pages 19022-19023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7589]
[[Page 19022]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development
Submission for OMB Review; Comment Request; New Proposed Collection,
Neuropsychosocial Formative Research Methodological Studies for the
National Children's Study
SUMMARY: Under the provisions of Section (3507(a)(1)(D)) of the
Paperwork Reduction Act of 1995, the National Institutes of Health has
submitted to the Office of Management and Budget (OMB) a request to
review and approve the information collection listed below. 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. Two written comments and two verbal comments were
received. The verbal comments expressed support for the broad scope of
the study. The written comments were identical and questioned the cost
and utility of the study. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Neuropsychosocial Formative Research
Methodological Studies for the National Children's Study (NCS). Type of
Information Request: NEW. Need and Use of Information Collection: The
Children's Health Act of 2000 (Pub. L. 106-310) states:
(a) PURPOSE.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct
a national longitudinal study of environmental influences (including
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 of 2000,
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 (Pilot) and Main Studies. With this
information collection request, the NCS seeks to obtain OMB's generic
clearance to conduct formative research featuring neuropsychosocial
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 (Pilot)
Study and Main Study neuropsychosocial 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/potential NCS
participants, infants, children, fathers, legal guardians, health care
facilities and professionals, hospital administrators and staff,
pediatric professional organizations and practitioners, educational
professionals, public health organizations, community leaders, members,
and organizations, and cultural and faith-based centers. 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: $742,000 (based on approximately $10 per
hour for NCS participants and members of the NCS target population
(non-NCS participants), $101 per hour for health providers (OB/GYNs),
and $20 per hour for social service providers). There are no capital
costs to report. There are no operating or maintenance costs to report.
Table 1--Estimated Annual Reporting Burden Summary, Neuropsychosocial Measures
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Physical measurement and NCS participants 4,000 1 1 4,000
examinations. 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
(cognitive). Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Computer-based reaction time NCS participants 4,000 1 1 4,000
testing. 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 Members of NCS 4,000 2 1 8,000
administration. target
population (not
NCS
participants).
Health Care 1,000 1 1 1,000
Providers.
Social Service 1,000 1 1 1,000
Providers.
[[Page 19023]]
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 Care 1,000 1 1 1,000
Providers.
Social Service 1,000 1 1 1,000
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
----------------------------------------------------------------------------------------------------------------
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 enhance the quality, utility, and
clarity of the information 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to Office of Management and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk Officer, by Email to OIRA_submission@omb.eop.gov, or by fax to 202-395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans and instruments, contact Ms. Jamelle E. Banks, Public
Health Analyst, Office of Science Policy, Analysis and Communication,
National Institute of Child Health and Human Development, 31 Center
Drive Room 2A18, Bethesda, Maryland 20892, or call a non-toll free
number (301) 496-1877 or Email your request, including your address to
banksj@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: March 21, 2012.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communications, National Institute of Child Health and Human
Development.
[FR Doc. 2012-7589 Filed 3-28-12; 8:45 am]
BILLING CODE 4140-01-P
