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Determining Causes of Sudden, Unexpected Infant Death: A National Survey of U.S. Medical Examiners and Coroners

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OMB: 0920-0999

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69485

Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Notices
project is to collect data on the
conditions surrounding and preceding
the onset of a problem. The data must
be collected in a timely fashion so that
information can be used to develop
prevention and control techniques, to
interrupt disease transmission and to
help identify the cause of an outbreak.
Since the events necessitating the
collections of information are of an
emergency nature, most data collection
is done by direct interview or written
questionnaire and are one-time efforts
related to a specific outbreak or
circumstance. If during the emergency
investigation, the need for further study
is recognized, a project is designed and
separate OMB clearance is required.
Interviews are conducted to be as
unobtrusive as possible and only the
minimal information necessary is
collected. The Emergency Epidemic
Investigations data collection project is
the principal source of data on
outbreaks of infectious and
noninfectious diseases, injuries,

nutrition, environmental health, and
occupational problems.
Each investigation contributes to the
general knowledge about a particular
type of problem or emergency, so that
data collections are designed taking into
account knowledge gained during
similar situations in the past. Some
questionnaires have been standardized,
such as investigations of outbreaks
aboard aircraft or cruise vessels.
The Emergency Epidemic
Investigations data collection project
provides a range of data on the
characteristics of outbreaks and those
affected by outbreaks. Data collected
include demographic characteristics of
the affected population, exposure to the
causative agent(s), transmission
patterns, and severity of the outbreak.
These data, together with trend data,
may be used to monitor the effects of
change in the health care system, plan
health services, improve the availability
of medical services, and assess the
health status of the population.

Users of the Emergency Epidemic
Investigations data include, but are not
limited to, Epidemic Intelligence
Service (EIS) officers of the CDC, who
investigate the patterns of disease or
injury, the level of risky behaviors,
causative agents, the transmission of the
condition, and the impact of
interventions. EIS is a two-year program
of training and service in applied
epidemiology through CDC, primarily
for persons holding doctoral degrees.
Predicting the number of epidemic
investigations that might occur in any
given year is difficult. The previous
three years’ experience shows an
annualized burden of 3,750 hours and
respondent total of 15,000. After
completion of the Epi-Aid investigation,
using the Epi-Aid Satisfaction Survey
for Requesting Officials, data are
collected from 100 state and local health
officials for an annualized total of 25
burden hours. For this clearance, CDC is
requesting 3,775 total burden hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Requestors of Epi-Aids ...................................

Epi-Aid Satisfaction Survey for Requesting
Official.
Emergency Epidemic Investigations ..............

General Public ................................................

Dated: November 13, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012–28083 Filed 11–16–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–13BU]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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Number of
respondents

Respondents

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

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the data collection plans and
instruments, call 404–639–7570 or send
comments to Ron Otten, 1600 Clifton
Road, MS D–74, Atlanta, GA 30333 or
send an email 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
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
Determining Causes of Sudden,
Unexpected Infant Death: A National
Survey of U.S. Medical Examiners and
Coroners—New—National Center for
Chronic Disease Prevention and Health

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Number of
responses per
respondent

Average
burden per
response
(in hours)

100

1

15/60

15,000

1

15/60

Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Each year in the United States,
approximately 4,200 infants die
suddenly without any cause that is
immediately obvious. Half of these
sudden unexpected infant deaths (SUID)
are attributed to Sudden Infant Death
Syndrome (SIDS), which is the leading
cause of death in infants between one
and twelve months of age. Reducing
deaths caused by SIDS and other SUID
such as accidental suffocation are
important public health priorities.
Between 1990 and 2001, the rate of
SIDS in the U.S. decreased from 1.3 per
1,000 live births to 0.56 deaths per 1,000
live births. The 50% decline in SIDS is
attributed to the success of the ‘‘Back to
Sleep’’ campaign, launched in 1994,
during which prone sleeping for infants
decreased from about 75% in 1992 to
12% in 2002. SIDS has continued to
decline slightly and in 2009 was
estimated to be 0.525 deaths per 1,000,
however, post-neonatal mortality due to
other causes increased, particularly in
1999–2001. Further examination of the
cause-specific age at death and month of

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Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Notices

death distributions suggested that cases
once reported as SIDS were
subsequently being reported as
accidental suffocation and strangulation
in bed or as cause unknown/
unspecified. Because SIDS, by
definition, is nonspecific, there is
substantial variation in how these
deaths are reported by the medical
examiner or coroner in the jurisdiction
of record. Some variation in the
classification of infant deaths may be
due to inconsistent use of terms and
definitions, and some variation may
reflect limitations of investigation and
documentation. Uncertainties in
classification negatively impact
understanding of the causes of infant
mortality and the ability to develop
appropriate public health responses.
CDC requests OMB approval to
conduct the first national,
geographically representative survey of
medical examiners and coroners that
concerns SUID diagnostic and reporting
practices. Information will be collected
to elucidate how medical examiners and
coroners interpret and report SUID and
the extent to which their interpretation
and reporting practices vary. The

practices and training, knowledge and
opinions about topics related to sudden
unexpected and unexplained infant
death, demographic characteristics, and
jurisdiction-specific training and
resource needs. Respondents will also
review hypothetical infant death case
descriptions and indicate how they
would classify the cause of death for
those cases. The questionnaire does not
request the respondent’s name, and
response data will be de-linked from the
information used for recruitment
purposes. Data analysis will be
conducted using de-identified
responses.
Survey findings will be used to
develop educational publications and
presentations aimed at improving the
consistent use of standardized terms
and definitions in determining the cause
of unexpected infant deaths. Findings
may also be applicable to the
development of public health programs
aimed at reducing unexpected infant
deaths.
OMB approval is requested for one
year. Participation is voluntary and
there are no costs to respondents other
than their time.

proposed activity is part of CDC’s
mission, as described in Section 241 of
the Public Health Service Act [42 U.S.C.
241].
CDC’s data collection contractor will
draw a sample of medical examiners
and coroners as follows. First, U.S.
counties will be selected (with
replacement) with probability
proportional to the number of SUIDrelated deaths reported from 2005–2009.
A sampling frame will be established for
each county and the appropriate
number of names will be randomly
selected from the list. An interviewer
will telephone approximately 800
offices to verify the name and contact
information of the individual
responsible for certifying infant deaths.
Paper questionnaires will then be
distributed to approximately 80 medical
examiners and 720 coroners by mail.
CDC expects to receive approximately
64 completed questionnaires from
medical examiners and 576 completed
questionnaires from coroners.
Questionnaires will take about 30
minutes to complete and will contain
questions about each respondent’s
reporting jurisdiction, reporting

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Receptionist or Operator ...................
Medical Examiner .............................

Telephone Screener .........................
National Survey of Medical Examiners and Coroners.
National Survey of Medical Examiners and Coroners.

Coroner .............................................
Total ...........................................

...........................................................

Dated: November 13, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012–28079 Filed 11–16–12; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act

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Total burden
(in hr)

1
1

5/60
30/60

67
32

576

1

30/60

288

........................

........................

........................

387

Board Public Meeting Times and Dates (All
times are Eastern Time): 8:15 a.m.–5:45 p.m.,
December 11, 2012. 8:15 a.m.–12:30 p.m.,
December 12, 2012.
Public Comment Times and Dates (All
times are Eastern Time): 6:00 p.m.–7:00
p.m.,* December 11, 2012.
* Please note that the public comment
periods may end before the times indicated,
following the last call for comments.
Members of the public who wish to provide
public comments should plan to attend
public comment sessions at the start times
listed.
Place: Hilton Knoxville, 501 West Church
Avenue, Knoxville, Tennessee 37902; Phone:
865–251–2573; Fax: 865–546–1716. Audio
Conference Call via FTS Conferencing. The

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burden per
response
(in hr)

Number of
responses per
respondent

800
64

(Pub. L. 92–463), and pursuant to the
requirements of 42 CFR 83.15(a), the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting of the
aforementioned committee:

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Number of
respondents

Type of respondent

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USA toll-free, dial-in number is 1–866–659–
0537 with a pass code of 9933701.
Status: Open to the public, limited only by
the space available. The meeting space
accommodates approximately 150 people.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines which
have been promulgated by the Department of
Health and Human Services (HHS) as a final
rule, advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program, and advice on petitions to add

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File Title2012-28079.pdf
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