National Institute of Child Health and Human Development; Submission for OMB Review; Comment Request; NEXT Generation Health Study, 48747-48749 [E9-23125]
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Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
FOR FURTHER INFORMATION CONTACT:
Jeritta Parnell, Contract Policy Division,
GSA (202) 501–4082 or e-mail
jeritta.parnell@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
Value engineering is the technique by
which contractors (1) voluntarily
suggest methods for performing more
economically and share in any resulting
savings or (2) are required to establish
a program to identify and submit to the
Government methods for performing
more economically. These
recommendations are submitted to the
Government as value engineering
change proposals (VECP’s) and they
must include specific information. This
information is needed to enable the
Government to evaluate the VECP and,
if accepted, to arrange for an equitable
sharing plan.
B. Annual Reporting Burden
Respondents: 400.
Responses per Respondent: 4.
Annual Responses: 1,600.
Hours per Response: 30.
Total Burden Hours: 48,000.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0027,
Value Engineering Requirements, in all
correspondence.
Dated: September 17, 2009.
Al Matera,
Director, Acquisition Policy Division.
[FR Doc. E9–23089 Filed 9–23–09; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
Nagendra S. Ningaraj, PhD,
Vanderbilt University School of
Medicine: Based on the reports of an
investigation conducted by Vanderbilt
University School of Medicine (VUSM)
and additional analysis by the Division
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16:27 Sep 23, 2009
Jkt 217001
of Investigative Oversight (DIO), ORI, in
its oversight review, found that
Nagendra S. Ningaraj, PhD, former
Associate Professor of Neurological
Surgery and Cancer Biology, VUSM,
engaged in scientific misconduct by
falsifying MALDI–MS images and mass
spectral tracings and associated text in
Figure 21 reported in National Cancer
Institute (NCI), National Institutes of
Health (NIH), grant application 1 U54
CA119421–01 and by falsifying MALDI–
MS images in a presentation during the
American Association for Cancer
Research (AACR) meeting held on April
16–20, 2005, which cited support from
NCI, NIH, grants R25 CA92943 and P50
CA098131.
Specifically, ORI found that:
1. Respondent reversed the images for
the control and minoxidil-treated brains
in Figure 21 of the 1 U54 CA119421–01
grant application, claiming that
minoxidil increased delivery of Gleevec
to the tumor. Respondent also reversed
the same images in a presentation
during the AACR meeting in April 2005.
2. In Figure 21 of the 1 U54
CA119421–01 grant application,
Respondent reported mass spectral
tracings as having been obtained from
brain tumors in Gleevec-treated mice
that had been pretreated with minoxidil,
while in fact they were pretreated with
another potassium channel opener,
NS1619, and Respondent falsely stated
the minoxidil pretreatment caused an
8-fold increase in Gleevec delivery to
brain tumors (compared to nonminoxidil pretreated tumors).
3. Respondent further falsified Figure
21 of the 1 U54 CA119421–01 grant
application by juxtaposing the reversed
MALDI–MS images (obtained with
mioxidil) with the mass spectral
tracings (obtained with NS1619) in the
same figure and by failing to report that
the images and spectra in the figure
were actually obtained in totally
different experiments, performed on
different dates and with different K+
agonist pretreatments.
Dr. Ningaraj has entered into a
Voluntary Settlement Agreement in
which he has voluntarily agreed, for a
period of three (3) years, beginning on
August 31, 2009:
(1) To be prohibited from serving in
any advisory capacity to PHS, including
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant;
(2) That any institution that submits
an application for PHS support for a
research project on which the
Respondent’s participation is proposed
or which uses him in any capacity on
PHS-supported research or that submits
a report of PHS-funded research on
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
48747
which he is involved must submit a
plan for supervision of his duties to the
funding agency for approval no later
than a month before the scheduled
funding; the supervisory plan must be
designed to ensure the scientific
integrity of his research contribution; a
copy of the supervisory plan also must
be submitted to ORI by the institution;
Respondent agrees that he will not
participate in any PHS-supported
research until such a supervisory plan is
submitted to ORI; and
(3) Respondent will ensure that any
institution employing him submits, in
conjunction with each application for
PHS funds or any report, manuscript, or
abstract of PHS-funded research in
which he is involved, a certification that
the data provided by him are based on
actual experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application or
report. Respondent must ensure that the
institution send the certification to ORI.
The certification shall be submitted no
later than one month before funding and
concurrently with any report,
manuscript, or abstract.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. E9–23046 Filed 9–23–09; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Submission for
OMB Review; Comment Request;
NEXT Generation Health Study
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 17, 2009,
Volume 74, Number 136, pages 34760–
34761 and allowed 60 days for public
comment. Two public comments were
received. One questioned the value of
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48748
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
this study and suggested that the study
could not possibly be completed within
the stated cost estimates. We have
always conducted extremely efficient
studies within stated cost estimates. The
value of this research is demonstrated
by the involvement of multiple
government agencies. The second e-mail
simply expressed interest in more
information. 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: NEXT Generation Health Study.
Type of Information Collection
Request: New.
Need and Use of Information
Collection:
The goal of this research is to obtain
data on adolescent health and health
behaviors annually for four years
beginning in the 2009–2010 school year
from a national probability sample of
adolescents. This information will
enable the improvement of health
services and programs for youth. The
study will provide needed information
about the health of U.S. adolescents.
The study will collect information on
adolescent health behaviors and social
and environmental contexts for these
behaviors annually for four years
beginning in the 2009–2010 school year.
Self-report of health status, health
behaviors, and health attitudes will be
collected by in-school and online
surveys. Anthropometric data, genetic
information, and neighborhood
characteristics will be gathered on all
participants as well. The study will also
incorporate a School Administrator
Survey and other data files to obtain
related information on school-level
health programs and community-level
contextual data. A representative
subsample of overweight and normal
weight adolescents will be identified
and additional data on behavioral risk
factors and biological markers and risk
factors will be gathered on these
adolescents.
TABLE 1—ANNUAL BURDEN FOR AFFECTED PUBLIC: SCHOOL-AGE CHILDREN, PARENTS AND SCHOOL ADMINISTRATORS
Estimated
number of respondents
Type of
respondents
Estimated
number of responses per
respondent
2,700
750
750
80
1
1
1
1
Adolescents .....................................................................................................
Adolescents with additional assessments .......................................................
Parents .............................................................................................................
School Administrators ......................................................................................
The estimated annualized cost to
respondents is $8,199 (Table 2). These
costs were estimated for the 2009/2010
survey year only, not the entire duration
of the project; annualized over the entire
duration of the project, these costs
would be reduced to $3,261. These
estimates were calculated using 2008
Department of Labor figures for wages of
principals in high schools (grades 9 and
Average
burden hours
per response
0.75
2.5
0.17
0.33
Estimated
total annual
burden hours
requested
11, 004
1,875
128
26
10) and of average wage and salaried
employees, and assuming an annual
increase of 3.75%, 50-week contract,
and 40-hour week.
TABLE 2—ANNUAL COST TO RESPONDENTS—2009/2010 SURVEY YEAR ONLY
Estimated
total annual
burden hours
requested
Type of respondents
srobinson on DSKHWCL6B1PROD with NOTICES
Adolescents .....................................................................................................
Adolescents with additional assessments .......................................................
Parents .............................................................................................................
School Administrators ......................................................................................
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
No direct costs to the respondents
themselves or to participating schools
are anticipated.
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
VerDate Nov<24>2008
16:27 Sep 23, 2009
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11,004
1,875
128
26
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:
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:
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
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Fmt 4703
Sfmt 4703
Estimated
annual earnings during
survey
$0.00
0.00
42,270
84,913
Average
hourly earnings (with
rounding)
$0.00
0.00
21.93
42.46
Estimated cost
during survey
year
$0.00
0.00
2,807
5,392
to obtain a copy of the data collection
plans and instruments, contact Dr.
Ronald Iannotti, Prevention Research
Branch, Division of Epidemiology,
Statistics, and Prevention Research,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, Building 6100, 7B05,
9000 Rockville Pike, Bethesda,
Maryland, 20892–7510, or call non-toll
free number (301) 435–6951 or E-mail
your request, including your address to
ri25j@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
E:\FR\FM\24SEN1.SGM
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48749
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
Dated: September 21, 2009.
Sarah Glavin,
Project Clearance Liaison, NICHD, National
Institutes of Health.
[FR Doc. E9–23125 Filed 9–23–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–0920–0747]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Longitudinal follow-up of Youth with
Attention-Deficit/Hyperactivity Disorder
identified in Community Settings:
Examining Health Status, Correlates,
and Effects associated with treatment for
Attention-Deficit/Hyperactivity Disorder
[OMB #0920–0747 exp. 7/31/1010]—
Revision—National Center on Birth
Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
This project will collect data from
proxy respondents and youths with and
without ADHD. This program addresses
the Healthy People 2010 focus area of
Mental Health and Mental Disorders,
and describes the prevalence, incidence,
long-term outcomes, treatment(s), select
co-morbid conditions, secondary
conditions, and health risk behavior of
youth with ADHD relative to youth
without ADHD.
The National Center on Birth Defects
and Developmental Disabilities at CDC
promotes the health of children with
developmental disorders. As part of
these efforts, two contracts were
awarded in FY 2007–2010 to follow up
a sample of children originally enrolled
in community-based epidemiological
research on ADHD among elementaryaged youth, known as the Project to
Learn about ADHD in Youth (PLAY
Study Collaborative), which informed
community-based prevalence, rates of
comorbidity, and rates of health risk
behaviors among elementary-age youth
with and without ADHD as determined
by a rigorous case definition developed
by the principal investigators and in
collaboration with CDC scientists.
The purpose of the longitudinal
follow-up program is to study the longterm outcomes and health status for
children with Attention-Deficit/
Hyperactivity Disorder (ADHD)
identified and treated in community
settings through a systematic follow-up
of the subjects who participated in the
PLAY Study Collaborative. There is a
considerable interest in the long-term
outcomes of youth with ADHD as well
as the effects of treatment, lack of
treatment, and quality of care in average
US communities, emphasizing the
public health importance of
longitudinal research in this area.
Given the lack of detailed information
about longitudinal development in
children with and without ADHD, there
is need to continue assessing the
children into older adolescence. This
program extends data collection for two
additional waves.
Minor changes to the assessment
instruments are planned in order to
include age appropriate assessment of
treatment and health risk behaviors in
older adolescents, such as
understanding motor vehicle operation
and dating behavior.
There are no costs to the respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
srobinson on DSKHWCL6B1PROD with NOTICES
Survey instruments (by type of respondent)
Parent:
ADHD Communication and Knowledge ...................................................
ADHD Treatment, Cost, and Client Satisfaction Questionnaire ...............
ADHD Treatment Questionnaire ...............................................................
Brief Impairment Scale .............................................................................
Critical School Events (Middle School) ....................................................
Critical School Events (High School) .......................................................
Demographic Survey ................................................................................
Health Risk Behavior Survey (Middle School) 11–13 years ....................
Health Risk Behavior Survey High School, 14+ years ............................
Parent-Child Relationship Inventory .........................................................
Parents’ Mental Health Questionnaire ......................................................
Quarterly update form ..............................................................................
Social Isolation/Support ............................................................................
Strengths and Difficulties Questionnaire (SDQ) .......................................
Vanderbilt Parent Rating Scale ................................................................
Child:
Brief Sensation Seeking Scale .................................................................
Conflict in Adolescent Dating Relationships .............................................
Health Risk Behavior Survey (Middle School) 11–13 years ....................
Health Risk Behavior Survey (High School)14+ years ............................
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16:27 Sep 23, 2009
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Frm 00041
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Sfmt 4703
Number of
responses/
respondent
Avg. burden/
response in
hours
Total burden
(in hours)
190
190
190
190
37
153
190
37
153
190
178
190
178
190
190
1
1
3
1
2
2
1
1
1
1
1
3
1
2
2
10/60
10/60
7/60
4/60
4/60
4/60
5/60
18/60
22/60
15/60
5/60
1/60
2/60
3/60
10/60
32
32
67
13
5
20
16
14
71
48
15
10
6
19
63
190
153
37
153
1
1
1
1
1/60
10/60
30/60
45/60
3
26
19
115
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 74, Number 184 (Thursday, September 24, 2009)]
[Notices]
[Pages 48747-48749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23125]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development;
Submission for OMB Review; Comment Request; NEXT Generation Health
Study
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Child Health and Human
Development (NICHD), the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on July 17, 2009, Volume 74, Number 136, pages 34760-34761 and
allowed 60 days for public comment. Two public comments were received.
One questioned the value of
[[Page 48748]]
this study and suggested that the study could not possibly be completed
within the stated cost estimates. We have always conducted extremely
efficient studies within stated cost estimates. The value of this
research is demonstrated by the involvement of multiple government
agencies. The second e-mail simply expressed interest in more
information. 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: NEXT Generation Health Study.
Type of Information Collection Request: New.
Need and Use of Information Collection:
The goal of this research is to obtain data on adolescent health
and health behaviors annually for four years beginning in the 2009-2010
school year from a national probability sample of adolescents. This
information will enable the improvement of health services and programs
for youth. The study will provide needed information about the health
of U.S. adolescents.
The study will collect information on adolescent health behaviors
and social and environmental contexts for these behaviors annually for
four years beginning in the 2009-2010 school year. Self-report of
health status, health behaviors, and health attitudes will be collected
by in-school and online surveys. Anthropometric data, genetic
information, and neighborhood characteristics will be gathered on all
participants as well. The study will also incorporate a School
Administrator Survey and other data files to obtain related information
on school-level health programs and community-level contextual data. A
representative subsample of overweight and normal weight adolescents
will be identified and additional data on behavioral risk factors and
biological markers and risk factors will be gathered on these
adolescents.
Table 1--Annual Burden for Affected Public: School-Age Children, Parents and School Administrators
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Adolescents..................................... 2,700 1 0.75 11, 004
Adolescents with additional assessments......... 750 1 2.5 1,875
Parents......................................... 750 1 0.17 128
School Administrators........................... 80 1 0.33 26
----------------------------------------------------------------------------------------------------------------
The estimated annualized cost to respondents is $8,199 (Table 2).
These costs were estimated for the 2009/2010 survey year only, not the
entire duration of the project; annualized over the entire duration of
the project, these costs would be reduced to $3,261. These estimates
were calculated using 2008 Department of Labor figures for wages of
principals in high schools (grades 9 and 10) and of average wage and
salaried employees, and assuming an annual increase of 3.75%, 50-week
contract, and 40-hour week.
Table 2--Annual Cost to Respondents--2009/2010 Survey Year Only
----------------------------------------------------------------------------------------------------------------
Estimated Estimated Average
total annual annual hourly Estimated cost
Type of respondents burden hours earnings earnings (with during survey
requested during survey rounding) year
----------------------------------------------------------------------------------------------------------------
Adolescents..................................... 11,004 $0.00 $0.00 $0.00
Adolescents with additional assessments......... 1,875 0.00 0.00 0.00
Parents......................................... 128 42,270 21.93 2,807
School Administrators........................... 26 84,913 42.46 5,392
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
No direct costs to the respondents themselves or to participating
schools are anticipated.
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: 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: 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 Dr. Ronald
Iannotti, Prevention Research Branch, Division of Epidemiology,
Statistics, and Prevention Research, Eunice Kennedy Shriver National
Institute of Child Health and Human Development, Building 6100, 7B05,
9000 Rockville Pike, Bethesda, Maryland, 20892-7510, or call non-toll
free number (301) 435-6951 or E-mail your request, including your
address to ri25j@nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
[[Page 48749]]
Dated: September 21, 2009.
Sarah Glavin,
Project Clearance Liaison, NICHD, National Institutes of Health.
[FR Doc. E9-23125 Filed 9-23-09; 8:45 am]
BILLING CODE 4140-01-P
