New Proposed Collection; Comment Request; Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study, 38191-38193 [2011-16299]
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38191
Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Biospecimen and Physical
Measures 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. This proposed
information collection was previously
published in the Federal Register on
April 27, 2011, pages 23609–23611, and
allowed 60 days for public comment.
One written comment was received. The
comment questioned the cost and utility
of the study and federally funded
biomedical research in general. The
purpose of this notice is to allow an
additional 30 days for public comment.
Proposed Collection:
Title: Biospecimen and Physical
Measures 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:
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, the results of
formative research tests will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of
biospecimen and physical measurement
collection procedures, accompanying
questionnaires, storage and information
management processes, and assay
procedures, thereby informing 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
biospecimen and physical measurement
collections.
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 biospecimen
collection procedures and physical
measurements 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, health care facilities and
professionals, public health professional
organizations and practitioners, and
hospital administrators.
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: $600,000 (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, BIOLOGICAL AND PHYSICAL MEASURES
Data collection activity
Blood:
Adult ......................................
Infant/Child ............................
mstockstill on DSK4VPTVN1PROD with NOTICES
Estimated
number of
respondents
Type of respondent
Urine:
Adult ......................................
Infant/Child ............................
Estimated number of responses
per respondent
Average burden
hours per
response
Estimated total
annual burden
hours requested
NCS participants .................
Members of NCS target
population (not NCS participants).
NCS participants .................
Members of NCS target
population (not NCS participants).
4,000
4,000
1
1
0.5
0.5
2,000
2,000
2,000
2,000
1
1
0.5
0.5
1,000
1,000
NCS participants .................
Members of NCS target
population (not NCS participants).
NCS participants .................
Members of NCS target
population (not NCS participants).
4,000
4,000
1
1
0.25
0.25
1,000
1,000
2,000
2,000
1
1
0.25
0.25
500
500
Hair:
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17:48 Jun 28, 2011
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38192
Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, BIOLOGICAL AND PHYSICAL MEASURES—Continued
Data collection activity
Adult ......................................
Estimated number of responses
per respondent
Average burden
hours per
response
Estimated total
annual burden
hours requested
Cervical Fluid:
Women ..................................
Breast Milk:
Women ..................................
Cord Blood:
Infant/Child ............................
Meconium:
Infant/Child ............................
Placenta:
Infant .....................................
Length:
Infant .....................................
Height:
Child ......................................
Weight:
Infant/Child ............................
Head Circumference:
Infant/Child ............................
Middle Upper Arm Circumference:
Infant/Child ............................
Ulnar Length:
Infant/Child ............................
Small, focused survey and instrument design and administration.
VerDate Mar<15>2010
17:48 Jun 28, 2011
NCS participants .................
Members of NCS target
population (not NCS participants).
4,000
4,000
1
1
0.25
0.25
1,000
1,000
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
4,000
4,000
1
1
0.5
0.5
2,000
2,000
NCS participants .................
Members of NCS target
population (not NCS participants).
4,000
4,000
1
1
0.5
0.5
2,000
2,000
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
4,000
4,000
1
1
0.25
0.25
1,000
1,000
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
2,000
2,000
1
1
0.25
0.25
500
500
NCS participants .................
Members of NCS target
population (not NCS participants).
NCS participants .................
2,000
2,000
1
1
0.25
0.25
500
500
4,000
2
1
8,000
Members of NCS target
population (not NCS participants).
Nails:
Adult ......................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Estimated
number of
respondents
Type of respondent
4,000
2
1
8,000
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38193
Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, BIOLOGICAL AND PHYSICAL MEASURES—Continued
Data collection activity
Focus groups ................................
Cognitive interviews ......................
Total ......................................
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).
.............................................
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.
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 30 days of the date of
this publication.
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
17:48 Jun 28, 2011
Estimated
number of
respondents
Type of respondent
Jkt 223001
Estimated number of responses
per respondent
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
113,000
............................
[FR Doc. 2011–16299 Filed 6–28–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases 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
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 Diabetes and Digestive and
Kidney Diseases Special Emphasis
Panel, Endogenous Insulin Secretion
Preservation.
Date: July 27, 2011.
Time: 8:30 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD
20817.
Frm 00086
Fmt 4703
Estimated total
annual burden
hours requested
2,000
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
PO 00000
Average burden
hours per
response
Sfmt 4703
..............................
60,000
Contact Person: Lakshmanan
Sankaran, PhD, Scientific Review
Officer, Review Branch, DEA, NIDDK,
National Institutes Of Health, Room 755,
6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7799,
ls38z@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: June 23, 2011
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–16298 Filed 6–28–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; 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/or contract proposals 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 and/or contract proposals,
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38191-38193]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16299]
[[Page 38191]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Biospecimen and
Physical 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 April 27, 2011, pages 23609-23611, and
allowed 60 days for public comment. One written comment was received.
The comment questioned the cost and utility of the study and federally
funded biomedical research in general. The purpose of this notice is to
allow an additional 30 days for public comment.
Proposed Collection:
Title: Biospecimen and Physical Measures 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 tests will be used to maximize the
efficiency (measured by scientific robustness, participant and
infrastructure burden, and cost) of biospecimen and physical
measurement collection procedures, accompanying questionnaires, storage
and information management processes, and assay procedures, thereby
informing 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 biospecimen and physical measurement collections.
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 biospecimen collection procedures and physical measurements 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, health care facilities and professionals, public health
professional organizations and practitioners, and hospital
administrators.
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: $600,000 (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, Biological and Physical Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Estimated number Average burden Estimated total
Data collection activity Type of respondent number of of responses per hours per annual burden
respondents respondent response hours requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Blood:
Adult.................................... NCS participants................ 4,000 1 0.5 2,000
Members of NCS target population 4,000 1 0.5 2,000
(not NCS participants).
Infant/Child............................. NCS participants................ 2,000 1 0.5 1,000
Members of NCS target population 2,000 1 0.5 1,000
(not NCS participants).
Urine:
Adult.................................... NCS participants................ 4,000 1 0.25 1,000
Members of NCS target population 4,000 1 0.25 1,000
(not NCS participants).
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Hair:
[[Page 38192]]
Adult.................................... NCS participants................ 4,000 1 0.25 1,000
Members of NCS target population 4,000 1 0.25 1,000
(not NCS participants).
Nails:
Adult.................................... NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Cervical Fluid:
Women.................................... NCS participants................ 4,000 1 0.5 2,000
Members of NCS target population 4,000 1 0.5 2,000
(not NCS participants).
Breast Milk:
Women.................................... NCS participants................ 4,000 1 0.5 2,000
Members of NCS target population 4,000 1 0.5 2,000
(not NCS participants).
Cord Blood:
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Meconium:
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Placenta:
Infant................................... NCS participants................ 4,000 1 0.25 1,000
Members of NCS target population 4,000 1 0.25 1,000
(not NCS participants).
Length:
Infant................................... NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Height:
Child.................................... NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Weight:
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Head Circumference:
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Middle Upper Arm Circumference:
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Ulnar Length:
Infant/Child............................. NCS participants................ 2,000 1 0.25 500
Members of NCS target population 2,000 1 0.25 500
(not NCS participants).
Small, focused survey and instrument design NCS participants................ 4,000 2 1 8,000
and administration.
Members of NCS target population 4,000 2 1 8,000
(not NCS participants).
[[Page 38193]]
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders.......... 2,000 1 1 2,000
Focus groups................................. NCS participants................ 2,000 1 1 2,000
Members of NCS target population 2,000 1 1 2,000
(not NCS participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders.......... 2,000 1 1 2,000
Cognitive interviews......................... NCS participants................ 500 1 2 1,000
Members of NCS target population 500 1 2 1,000
(not NCS participants).
----------------------------------------------------------------------------------------------------------
Total.................................... ................................ 113,000 ................ ................. 60,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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. 2011-16299 Filed 6-28-11; 8:45 am]
BILLING CODE 4140-01-P
