Submission for OBM Review; Comment Request; New Proposed Collection, Environmental Science Formative Research Methodology Studies for the National Children's Study, 62077-62079 [2011-25868]
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Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
62077
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Daniel R. Levinson,
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[FR Doc. 2011–25894 Filed 10–5–11; 8:45 am]
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Submission for OBM Review;
Comment Request; New Proposed
Collection, Environmental Science
Formative Research Methodology
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 (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for reinstatement of
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 27, 2011,
pages 23603–23605, 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:
Environmental Science Formative
Research Methodology 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.
E:\FR\FM\06OCN1.SGM
06OCN1
62078
Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
(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
environmental sample collection
procedures and technology, storage
procedures, accompanying
questionnaires, and assays, 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 collect
environmental samples from homes and
child care settings, and conduct
accompanying short surveys related to
the physical and chemical environment.
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
environmental sample and information
collection 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, fathers, public health and
environmental science 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: $780,000 (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
Data collection activity
Type of respondent
Home Air .......................................................
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
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
4,000
2
1
8,000
2,000
1
1
2,000
2,000
2,000
2,000
1
1
1
1
1
1
2,000
2,000
2,000
2,000
1
1
2,000
2,000
500
500
1
1
1
1
2
2
2,000
1,000
1,000
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).
NCS participants ...................
Members of NCS target population (not NCS participants).
NCS participants ...................
Members of NCS target population (not NCS participants).
NCS participants ...................
Home Water ..................................................
Home Dust ....................................................
School and Child Care Facility Air ...............
School and Child Care Facility Water ..........
School and Child Care Facility Dust ............
Small, focused survey and instrument design and administration.
Focus groups ................................................
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Estimated
number of responses per
respondent
Cognitive interviews ......................................
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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).
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62079
Federal Register / Vol. 76, No. 194 / Thursday, October 6, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE—Continued
Data collection activity
Total .......................................................
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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 E-mail 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 E-mail 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: September 30, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science
Policy, Analysis and Communications,
National Institute of Child Health and Human
Development.
[FR Doc. 2011–25868 Filed 10–5–11; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
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Estimated
number of respondents
Type of respondent
Estimated
number of responses per
respondent
Average burden hours per
response
Estimated total
annual burden
hours requested
69,000
........................
........................
78,000
...............................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; 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 a meeting of the Board
of Scientific Counselors for Basic
Sciences National Cancer Institute.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors for Basic Sciences National
Cancer Institute.
Date: November 15, 2011.
Time: 9 a.m. to 4 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 6,
Bethesda, MD 20892.
Contact Person: Florence E. Farber, PhD,
Executive Secretary, Office of the Director,
National Cancer Institute, National Institutes
of Health, 6116 Executive Boulevard, Room
2205, Bethesda, MD 20892, 301–496–7628,
ff6p@nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/bsc/bs/bs.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: September 30, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–25897 Filed 10–5–11; 8:45 am]
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HUMAN SERVICES
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,
Fellowships: Physiology and Pathobiology of
Musculoskeletal, Oral, and Skin Systems.
Date: October 26, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Abdelouahab Aitouche,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4222,
MSC 7812, Bethesda, MD 20892, 301–435–
2365, aitouchea@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR Panel:
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]]>Agencies
[Federal Register Volume 76, Number 194 (Thursday, October 6, 2011)]
[Notices]
[Pages 62077-62079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25868]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OBM Review; Comment Request; New Proposed
Collection, Environmental Science Formative Research Methodology
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
(NIH) has submitted to the Office of Management and Budget (OMB) a
request for reinstatement of approval of the information collection
listed below. This proposed information collection was previously
published in the Federal Register on April 27, 2011, pages 23603-23605,
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: Environmental Science Formative
Research Methodology 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.
[[Page 62078]]
(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 environmental sample collection procedures and
technology, storage procedures, accompanying questionnaires, and
assays, 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 collect
environmental samples from homes and child care settings, and conduct
accompanying short surveys related to the physical and chemical
environment.
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 environmental sample and information collection 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,
fathers, public health and environmental science 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: $780,000 (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 burden total annual
Data collection activity respondent number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Home Air...................... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Home Water.................... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
Home Dust..................... NCS participants 4,000 1 1 4,000
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
School and Child Care Facility NCS participants 4,000 1 1 4,000
Air.
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
School and Child Care Facility NCS participants 4,000 1 1 4,000
Water.
Members of NCS 4,000 1 1 4,000
target
population (not
NCS
participants).
School and Child Care Facility NCS participants 4,000 1 1 4,000
Dust.
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.
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).
---------------------------------------------------------------------------------
[[Page 62079]]
Total..................... ................ 69,000 .............. .............. 78,000
----------------------------------------------------------------------------------------------------------------
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 E-mail 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 E-mail 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: September 30, 2011.
Jamelle E. Banks,
Public Health Analyst, Office of Science Policy, Analysis and
Communications, National Institute of Child Health and Human
Development.
[FR Doc. 2011-25868 Filed 10-5-11; 8:45 am]
BILLING CODE 4140-01-P
