Submission for OMB Emergency Review; Comment Request: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI), 9665-9666 [2012-3830]
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9665
Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices
Maryland 20857 or email
cdykton@hrsa.gov.
Amount of the Award(s): Up to
$196,506 per grantee over a one-year
project period.
CFDA Number: 93.110.
Current Project Period: 7/1/2007
through 6/30/2012.
Period of Supplemental Funding:
7/1/2012 through 6/30/2013.
Proposed Collection: Title: A MultiCenter International Hospital-Based
Case-Control Study of Lymphoma in
Asia (AsiaLymph) (NCI). Type of
Information Collection Request:
Emergency. Need and Use of
Information Collection: Incidence rates
of certain lymphomas have increased in
several centers in Asia thereby
increasing the cancer burden in these
populations, but the causes remain
unknown. AsiaLymph is a multidisciplinary case-control study that will
confirm and extend previous findings
and yield novel insights into the causes
of lymphoma in both Asia and the West.
The major postulated risk factors for
evaluation in this study are chemical
exposures (i.e., organochlorines,
trichloroethylene, and benzene) and
genetic susceptibility. Other factors
potentially related to lymphoma, such
as viral infections, ultraviolet radiation
exposure, medical conditions, and other
lifestyle factors will also be studied.
Patterns of key risk factors, including
range of exposures, prevalence of
exposures, correlations between
exposures, and variation in gene regions
are of particular interest. Patients from
19 participating hospitals will be
screened and enrolled. There will be a
one-time computer-administered
interview, and patients will also be
asked to provide a one-time blood and
buccal cell mouth wash sample and
lymphoma cases will be asked to make
available a portion of their pathology
sample. Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Newly diagnosed patients
with lymphoma or patients undergoing
surgery or other treatment for noncancer related medical issues who live
in Hong Kong, Taiwan, and Chengdu
and Tianjin, China will be enrolled at
treating hospitals. The annual reporting
burden is estimated at 3,377 hours (see
Table below). There are no Capital
Costs, Operating Costs, and/or
Maintenance Costs to report.
Dated: February 10, 2012.
Mary K. Wakefield,
Administrator.
[FR Doc. 2012–3792 Filed 2–16–12; 8:45 am]
BILLING CODE 4165–15–P
Authority: Title V of the Social Security
Act, Section 501(a)(2) (42 U.S.C. 701(a)(2)).
Justification
HRSA is extending funding for the
Leadership Training in Pediatric
Dentistry grants by one year for the
following reason: MCHB has been
working with leaders within HRSA
involved in oral health, the Bureau of
Health Professions (BHPr) on oral health
training investments, and other oral
health leaders in the field to align its
leadership training in oral health with
HRSA’s other oral health training
investments. With HRSA prioritizing
oral health integration in primary care,
MCHB is focusing on the best possible
use of its funds to continue to promote
oral health training in a coordinated
way related to efforts and initiatives
within HRSA and the field.
HRSA’s BHPr plans to hold a
stakeholders meeting on oral health
training in 2012 that would impact the
scope and nature of all HRSA’s oral
health training initiatives. To ensure
coordinated and non-duplicative HRSA
program planning and future oral health
grant funding, it is crucial to fund
MCHB’s current training program for
one year to sustain MCH oral health
leadership training, while developing
the next MCH oral health leadership
training initiative in a systemically
coordinated way with other HRSA oral
health training initiatives.
FOR FURTHER INFORMATION CONTACT:
Christopher Dykton, Health Resources
and Services Administration, Maternal
and Child Health Bureau, 5600 Fishers
Lane, Room 18A–55, Rockville,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Emergency
Review; Comment Request: A MultiCenter International Hospital-Based
Case-Control Study of Lymphoma in
Asia (AsiaLymph) (NCI)
Summary: In accordance with Section
3507(j) of the Paperwork Reduction Act
of 1995, the National Cancer Institute
(NCI), the National Institutes of Health
(NIH), has submitted to the Office of
Management and Budget (OMB) a
request for emergency review and
processing this information collection
by March 5, 2012. NCI is requesting
emergency processing of this
information collection, pursuant to 5
CFR 1320.13, because NCI cannot
reasonably comply with the normal
clearance procedures which would
cause a delay and likely prevent or
substantially disrupt the collection of
information. A delay in starting the
information collection would hinder the
agency in accomplishing its mission to
the detriment of the public good. Public
harm could result through the loss of
critically needed information to
understand and reduce the cancer
burden from lymphoid malignancies in
the Asian population. 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.
ESTIMATES OF ANNUAL BURDEN HOURS
Individuals .........
mstockstill on DSK4VPTVN1PROD with NOTICES
Types of respondents
Patients to be Screened ...................................................
Patients with Lymphoma ..................................................
Other Patients ...................................................................
Study Pathologists ............................................................
Interviewers ......................................................................
3,100
1,100
1,100
19
19
1
1
1
58
116
5/60
105/60
105/60
5/60
30/60
258
963
963
92
1102
Total ...........
...........................................................................................
........................
........................
........................
3,377
Request for Comments: Written
comments and/or suggestions from the
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19:08 Feb 16, 2012
Jkt 226001
Number of
respondents
public and affected agencies should
address one or more of the following
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Frequency of
response
Average time
per response
(Hours)
Category of
respondents
Annual burden
hours
points: (1) Evaluate whether the
proposed collection of information is
E:\FR\FM\17FEN1.SGM
17FEN1
9666
Federal Register / Vol. 77, No. 33 / Friday, February 17, 2012 / Notices
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) evaluate 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) enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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 the
Attention: NIH Desk Officer, Office of
Management and Budget, at
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
Nathaniel Rothman, Senior Investigator
for the Occupational and Environmental
Epidemiology Branch, Division of
Epidemiology and Genetics, National
Cancer Institute, 6120 Executive
Boulevard, Room 8118, Rockville, MD
20892 or call non-toll-free number 301–
496–9093 or email your request,
including your address to:
rothmann @mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 15 days of the date of
this publication.
Dated: February 13, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–3830 Filed 2–16–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institutes of Health
National Institute of Child Health and
Human Development; New Proposed
Collection; Comment Request Stress
and Cortisol Measurement 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
VerDate Mar<15>2010
19:08 Feb 16, 2012
Jkt 226001
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Stress and Cortisol
Measurement Substudy for the National
Children’s Study (NCS). Type of
Information Collection 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 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 Stress and
Cortisol Measurement Substudy will
develop an optimized, item-reduced
measure of self-reported stress that is
supported empirically through
convergent validity analysis of stress
biomarkers. Specifically, key
moderators of stress biomarkers will be
evaluated to inform the efficiency and
quality of measurements during
pregnancy. Development of a
scientifically robust maternal stress
measure would measure chronic stress
more efficiently, would not require
biospecimen collection and biomarker
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
analyses, and would thereby reduce
participant burden and NCS Vanguard
(Pilot) and NCS Main Study costs. With
this information collection request, the
NCS seeks to obtain OMB’s clearance to
conduct a substudy aimed at developing
a validated questionnaire that will
reflect specific biological and
physiological measures of maternal
stress.
Background
The National Children’s Study is a
prospective, national longitudinal study
of the interaction between environment,
genetics on child health and
development. The Study defines
‘‘environment’’ broadly, taking a
number of natural and man-made
environmental, biological, genetic, and
psychosocial factors into account. By
studying children through their
different phases of growth and
development, researchers will be better
able to understand the role these factors
have on health and disease. Findings
from the Study will be made available
as the research progresses, making
potential benefits known to the public
as soon as possible. The National
Children’s Study is led by a consortium
of federal partners: the U.S. Department
of Health and Human Services (https://
www.hhs.gov/) (including the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(https://www.nichd.nih.gov/) and the
National Institute of Environmental
Health Sciences (https://
www.niehs.nih.gov/) of the National
Institutes of Health (https://
www.nih.gov/) and the Centers for
Disease Control and Prevention (https://
www.cdc.gov/)), and the U.S.
Environmental Protection Agency
(https://www.epa.gov/).
To conduct the detailed preparation
needed for a study of this size and
complexity, the NCS was designed to
include a preliminary pilot study
known as the Vanguard Study. The
purpose of the Vanguard Study is to
assess the feasibility, acceptability, and
cost of the recruitment strategy, study
procedures, and outcome assessments
that are to be used in the NCS Main
Study. The Vanguard Study begins prior
to the NCS Main Study and will run in
parallel with the Main Study. At every
phase of the NCS, the multiple
methodological studies conducted
during the Vanguard phase will inform
the implementation and analysis plan
for the Main Study.
In this information collection request,
the NCS requests approval from OMB to
perform a multi-center substudy, called
the Stress and Cortisol Measurement
Substudy. This substudy aims to
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 77, Number 33 (Friday, February 17, 2012)]
[Notices]
[Pages 9665-9666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Emergency Review; Comment Request: A Multi-
Center International Hospital-Based Case-Control Study of Lymphoma in
Asia (AsiaLymph) (NCI)
Summary: In accordance with Section 3507(j) of the Paperwork
Reduction Act of 1995, the National Cancer Institute (NCI), the
National Institutes of Health (NIH), has submitted to the Office of
Management and Budget (OMB) a request for emergency review and
processing this information collection by March 5, 2012. NCI is
requesting emergency processing of this information collection,
pursuant to 5 CFR 1320.13, because NCI cannot reasonably comply with
the normal clearance procedures which would cause a delay and likely
prevent or substantially disrupt the collection of information. A delay
in starting the information collection would hinder the agency in
accomplishing its mission to the detriment of the public good. Public
harm could result through the loss of critically needed information to
understand and reduce the cancer burden from lymphoid malignancies in
the Asian population. 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: A Multi-Center International Hospital-
Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type of
Information Collection Request: Emergency. Need and Use of Information
Collection: Incidence rates of certain lymphomas have increased in
several centers in Asia thereby increasing the cancer burden in these
populations, but the causes remain unknown. AsiaLymph is a multi-
disciplinary case-control study that will confirm and extend previous
findings and yield novel insights into the causes of lymphoma in both
Asia and the West. The major postulated risk factors for evaluation in
this study are chemical exposures (i.e., organochlorines,
trichloroethylene, and benzene) and genetic susceptibility. Other
factors potentially related to lymphoma, such as viral infections,
ultraviolet radiation exposure, medical conditions, and other lifestyle
factors will also be studied. Patterns of key risk factors, including
range of exposures, prevalence of exposures, correlations between
exposures, and variation in gene regions are of particular interest.
Patients from 19 participating hospitals will be screened and enrolled.
There will be a one-time computer-administered interview, and patients
will also be asked to provide a one-time blood and buccal cell mouth
wash sample and lymphoma cases will be asked to make available a
portion of their pathology sample. Frequency of Response: Once.
Affected Public: Individuals. Type of Respondents: Newly diagnosed
patients with lymphoma or patients undergoing surgery or other
treatment for non-cancer related medical issues who live in Hong Kong,
Taiwan, and Chengdu and Tianjin, China will be enrolled at treating
hospitals. The annual reporting burden is estimated at 3,377 hours (see
Table below). There are no Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Category of respondents Types of respondents Number of Frequency of per response Annual burden
respondents response (Hours) hours
----------------------------------------------------------------------------------------------------------------
Individuals............... Patients to be 3,100 1 5/60 258
Screened.
Patients with 1,100 1 105/60 963
Lymphoma.
Other Patients...... 1,100 1 105/60 963
Study Pathologists.. 19 58 5/60 92
Interviewers........ 19 116 30/60 1102
-------------------------------------------------------------------------------------
Total................. .................... .............. .............. .............. 3,377
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is
[[Page 9666]]
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2)
evaluate 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) enhance the quality, utility, and
clarity of the information to be collected; and (4) 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 the Attention: NIH Desk Officer, Office of Management and
Budget, at 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 Nathaniel Rothman,
Senior Investigator for the Occupational and Environmental Epidemiology
Branch, Division of Epidemiology and Genetics, National Cancer
Institute, 6120 Executive Boulevard, Room 8118, Rockville, MD 20892 or
call non-toll-free number 301-496-9093 or email your request, including
your address to: rothmann @mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 15 days
of the date of this publication.
Dated: February 13, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-3830 Filed 2-16-12; 8:45 am]
BILLING CODE 4140-01-P
