30dyFRN2010-10587

30dyFRN2010-10587.pdf

Early Hearing Detection and Intervention Hearing Screening and Follow-up survey

30dyFRN2010-10587

OMB: 0920-0733

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24704

Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices

with LPS. Respondent also used a
second image twice, labeling it once as
‘‘no LPS’’ and the second time as ‘‘24
hours with LPS.’’
11. Respondent knowingly and
intentionally falsified a figure that
purports to represent viral decay in
rectal mucosa and included the figure as
a slide in two PowerPoint presentations
and three NIH grant applications.
12. Respondent knowingly and
intentionally falsified: (a) A
histopathology figure that was described
in a paper published in the Journal of
Infectious Diseases 83:1466, 2001, as
inguinal lymph nodes from an untreated
AIDS patient using in situ PCR to show
the presence of HIV–1 cells when it was
actually from a tissue expressing the
neomycin marker; (b) the gel images
resembling Figures 2A and C, which
Respondent claimed to be based on
lymph node cells, although he reported
the gel images elsewhere to represent
results from rectal tissue; and (c) various
versions of these blots that Respondent
reported elsewhere and labeled
differently with respect to the copy
numbers detected and as detecting DNA
in some instance and RNA in others.
13. Respondent knowingly and
intentionally falsified Figures 2DI and
2DII included in a paper published in
the Journal of Leukocyte Biology
68:351–359, 2000.
14. Respondent knowingly and
intentionally falsified Figure 4, Panels A
and B, in NIDCR, NIH, grant application
1 R01 DE014827–01 by manipulating
the source images.
15. Respondent knowingly and
intentionally falsified a number of
figures and made false statements in the
text of NIAID, NIH, grant application 1
R01 AI051954–01 submitted jointly
with a colleague by relabeling figures
based on research carried out with HIV–
1 or HIV–2 and identifying the figures
and text as research conducted with
ovine lentivirus (OvLV).
ORI issued a charge letter
enumerating the above findings of
misconduct in science and proposing
HHS administrative actions. Dr. Brodie
subsequently requested a hearing before
an Administrative Law Judge (ALJ) of
the Departmental Appeals Board to
dispute these findings. In January 2009,
the ALJ issued a ruling holding that
there were no triable issues challenging
ORI’s findings that there were materially
false statements, images, and other data
in the relevant publications,
presentations, and grant applications.
However, the ALJ held that Dr. Brodie
raised triable issues about his intent to
commit scientific misconduct and the
reasonableness of the proposed
debarment of seven (7) years.

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On January 12, 2010, the ALJ issued
a recommended decision to the HHS
Assistant Secretary for Health (ASH)
granting summary disposition to ORI.
The ALJ also stated that Dr. Brodie
committed scientific misconduct on
multiple occasions and that its extent
amply justified debarment for a period
of seven (7) years. Pursuant to 42 CFR
93.523(c), the ASH forwarded the ALJ’s
recommended decision to the HHS
Debarring Official, which constituted
the findings of fact required under 2
CFR parts 180 and 376.
On February 1, 2010, Dr. Brodie
submitted a letter to the HHS Debarring
Official with attachments to request that
the ALJ’s recommended decision be
rejected as a whole. On February 26,
2010, Dr. Brodie submitted a letter
requesting the opportunity to meet with
the HHS Debarring Official to orally
present the reasons supporting his
request that the ALJ’s recommended
decision be rejected. However, the HHS
Debarring Official determined that Dr.
Brodie had been afforded an
opportunity to contest ORI’s findings of
scientific misconduct in accordance
with 42 CFR part 93, subpart E. Given
the findings of facts in this case, the
HHS Debarring Official determined that
the issues in his presentation in
opposition to the ALJ’s recommended
decision did not raise a genuine dispute
over facts material to the recommended
debarment. Accordingly, the HHS
Debarring Official also denied Dr.
Brodie’s request to make an oral
presentation and issued a notice of
debarment to begin on March 18, 2010,
and end on March 17, 2017.
On March 23, 2010, Dr. Brodie
submitted a letter requesting a
postponement of the effective date of
the debarment. This request was denied
by the Debarring Official on April 6,
2010.
Thus, the misconduct in science
findings set forth above became
effective, and the following
administrative actions have been
implemented for a period of seven (7)
years, beginning on March 18, 2010:
(1) Dr. Brodie has been debarred from
any contracting or subcontracting with
any agency of the United States
Government and from eligibility or
involvement in nonprocurement
programs of the United States
Government referred to as ‘‘covered
transactions’’ pursuant to the
Department of Health and Human
Service’s Implementation (2 CFR part
376 et seq.) of OMB Guidelines to
Agencies on Governmentwide
Debarment and Suspension, 2 CFR part
180; and

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(2) Dr. Brodie is 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
consultant.
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. 2010–10605 Filed 5–4–10; 8:45 am]
BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–0733]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call Maryam I. Daneshvar, the
CDC Reports Clearance Officer, at (404)
639–5960 or send an e-mail to
[email protected]. Send written comments
to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Early Hearing Detection and
Intervention Hearing Screening and
Follow-up Survey (OMB No. 0920–0733
exp. 10/31/2009)—Reinstatement With
Change—National Center on Birth
Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Center on Birth Defects
and Developmental Disabilities at CDC
promotes the health of babies, children,
and adults with disabilities. As part of
these efforts the Center is actively
involved in addressing hearing loss (HL)
among newborns and infants. HL is a
common birth defect that affects
approximately 12,000 infants each year
and, when left undetected, can result in
developmental delays. As awareness
about infant HL increases, so does the

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Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices
demand for accurate information about
rates of screening, referral, loss to
follow-up, and prevalence. This
information is important for: (a) Helping
to ensure infants and children are
receiving recommended screening and
follow-up services, (b) identifying
reasons for not receiving recommended
services and (c) documenting the
occurrence of differing degrees of HL
among infants. These data will also
assist the States in Early Hearing
Detection and Intervention (EHDI)
programs with quality improvement
activities and provide information that
will be helpful in assessing the impact

of Federal initiatives. The public will be
able to access this information via the
CDC EHDI Web site (http://
www.cdc.gov/ncbddd/ehdi).
Given the lack of a standardized and
readily accessible source of data, the
CDC EHDI program developed a survey
to be used annually that utilizes
uniform definitions to collect aggregate,
standardized EHDI data from States and
territories. The request to complete this
survey is planned to be disseminated to
57 respondents via an e-mail, which
will include a summary of the request
and other relevant information. We
anticipate that about 50 of the 57

coordinators will complete and return
the survey. Minor changes to this
survey, based on respondent feedback,
are planned in order to make the survey
easier to complete and further improve
data quality. These changes include
adding a question about how many
infants with hearing loss are receiving
only monitoring services, simplifying
the table for reporting type and severity
of hearing loss data, and expanding the
maternal race categories in the
demographic section. There are no costs
to the respondents other than their time.
The estimated annualized burden hours
are 210.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Respondents

EHDI Program State Program Coordinators Contacted .............................................................
EHDI Program State Program Coordinators Who Return the Survey ........................................

Dated: April 28, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–10587 Filed 5–4–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–10–10CV]

sroberts on DSKD5P82C1PROD with NOTICES

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.
Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road,
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
[email protected].
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 a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the

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proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify 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 information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
Early Aberration Reporting System
(EARS) Registration Module—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID)
(proposed), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
To support two of CDC’s main priority
areas: (1) Improving CDC’s support for
state and local health departments, and
(2) strengthening surveillance and
epidemiology, CDC is requesting
approval from the Office of Management
and Budget (OMB) to improve the Early
Aberration Reporting System (EARS) by
collecting data from individuals who
request a download of EARS from the
CDC website.
The Early Aberration Reporting
System, developed within the Division
of Bioterrorism Preparedness and
Response, is a web-enabled tool that
analyzes public health surveillance data
using methods that detect abnormal
trends that could possibly indicate an
outbreak of infectious disease. The local
public health professionals manage the
entire tool and can implement the
defaults or can adjust the tool in order
to meet their local needs. The goal of

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57
50

Number of responses per
respondent
1
1

Average
burden per
response
(in hours)
10/60
4

this process is to assist public health
professionals in the early identification
of outbreaks of disease as well as
bioterrorism events. EARS is used to
assess whether the current number of
reported cases of an event is higher than
usual.
The term syndromic surveillance is
used to describe surveillance that uses
health-related data that precede
diagnosis and that signals a sufficient
probability of a case or an outbreak of
infectious disease to warrant further
public health response. Syndromic
surveillance systems are used by state,
local, national and international health
departments to monitor syndrome-based
(e.g., case information collected in
emergency departments (EDs) and
diagnostic data sources for early
detection of outbreaks and other public
health events). More recently these
systems are used during public health
responses to provide more rapid near
real-time situational awareness
regarding the health status of the target
population. EARS was the first software
platform to support local syndromic
surveillance systems. EARS has been
designed and used to monitor
syndromic data from emergency
departments, 911 calls, physician office
data, school and business absenteeism,
over-the-counter drug sales, laboratory
testing and results data and reportable
disease surveillance systems. In the past
several years, EARS systems have been
integral in the local public health
surveillance arsenal. EARS has been
used at events such as the Beijing
Summer Olympics; multiple

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File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2010-05-05
File Created2010-05-05

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