Proposed Data Collections Submitted for Public Comment and Recommendations, 58395-58396 [2012-23197]
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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
[FR Doc. 2012–23203 Filed 9–19–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-12–12RP]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
mstockstill on DSK4VPTVN1PROD with NOTICES
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 404–639–7570 or send
comments to Kimberly S. Lane, at 1600
Clifton Road, MS D74, Atlanta, GA
30333 or send an email 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
Assessment of the Psychosocial
Impact of Newborn Screening for
Congenital Cytomegalovirus (CMV)
Infection—New—National Center for
Immunization and Respiratory Diseases
(NCIRD) and National Center on Birth
VerDate Mar<15>2010
16:11 Sep 19, 2012
Jkt 226001
Background and Brief Description
Each year in the United States, more
than 30,000 children are born with
congenital CMV infection.
Approximately 80% develop normally,
while the remaining 20% are born with
or subsequently develop disabilities
such as hearing loss or mental
retardation. A similar number of
children are affected by serious CMVrelated disabilities than by several
better-known childhood conditions,
including Down syndrome and spina
bifida.
The birth prevalence of congenital
CMV infection is several times higher
than the combined birth prevalence of
all metabolic or endocrine disorders in
the core U.S. newborn screening panel.
Because newborn CMV screening is
rarely performed, and because a
definitive diagnosis of congenital CMV
requires access to urine, saliva, or blood
collected soon after birth, most infected
children are never diagnosed. Newborn
CMV screening offers some clear
potential benefits, but few studies have
assessed the potential for harm (e.g.,
increased parental anxiety, ‘‘fragile
child syndrome’’).
CDC is requesting OMB approval for
one year to collect information about
newborn CMV screening. The purpose
of this information collection is to
understand the psychosocial impact of
newborn screening on parents whose
infants underwent CMV screening as
part of a routine infant CMV screening
program in Houston, Texas. The
potential study population includes
approximately 70 CMV-infected
children who were symptomatic at
birth, 100 CMV-infected children who
were asymptomatic at birth (20 of whom
developed sequelae), and 50 controls
that were CMV-uninfected. The goals of
this information collection are to: (1)
Document the positive and negative
psychosocial impacts of newborn CMV
screening on parents and their children;
(2) identify modifiable factors that might
increase positive psychosocial impacts
and decrease negative psychosocial
impacts of newborn CMV screening; (3)
use what is learned about psychosocial
impacts to identify key messages that
parents need relative to newborn CMV
screening and follow-up; and (4) to
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
58395
learn what challenges are associated
with obtaining a congenital CMV
diagnosis in the absence of CMV
newborn screening.
Much of the potential study
population is unique in that their
children experienced newborn CMV
screening as part of a previous research
study. Universal CMV screening has not
been recommended by medical
associations or state or federal
governments and as a result newborn
CMV screening is not typically
performed. The parents’ experience
with CMV screening and follow-up will
help inform decisions about whether
newborn CMV screening would be good
public health policy. This study
represents the first assessment of the
experiences of parents whose children
were screened for CMV at birth.
Respondents fall into four categories
depending on the past experiences of
their child who was screened for CMV:
• Parent Group 1 (PG1)—Child
screened positive for congenital CMV at
birth, asymptomatic at birth, but did not
develop sequelae.
• Parent Group 2 (PG2)—Child
screened positive for congenital CMV at
birth, asymptomatic at birth, but did
subsequently develop sequelae (e.g.,
hearing loss).
• Parent Group 3 (PG3)—Child was
diagnosed with congenital CMV and
had symptoms at birth.
• Parent Group 4 (PG4)—Child
screened negative for congenital CMV at
birth.
Information will be collected from
PG1 via focus groups, from PG2 and
PG3 via interviews, and from all four
parent groups via a mail survey. The
focus group, interview and survey
respondents will be asked to participate
only once. It is estimated that 71 parents
will participate in either individual
interviews or focus groups and that 230
will participate in the mail survey. The
interviews are planned to take 60
minutes while the focus groups will be
held for 90 minutes. The survey is
estimated to take 10 minutes per
respondent to complete and mail based
on previous administrations reported in
the literature. Reading and responding
to the focus group and interview
recruitment letters is estimated to take
5 minutes each. There is no cost to
respondents other than their time.
E:\FR\FM\20SEN1.SGM
20SEN1
58396
Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden hours
Parent category
Form name
Parent Group 1 .................................
Parent Groups 1, 2, 3, and 4 ............
Focus Group Guide ..........................
Focus group recruitment letter .........
Interviewer guide ..............................
Interview recruitment letter ...............
Survey ..............................................
36
50
35
50
230
1
1
1
1
1
1.5
5/60
1
5/60
10/60
54
4
35
4
38
Total Burden Hours ...................
...........................................................
........................
........................
........................
135
Parent Groups 2 and 3 .....................
Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2012–23197 Filed 9–19–12; 8:45 am]
BILLING CODE 4163–18–P
Proposed Project
Exposure Assessment and
Epidemiological Study of U.S. Workers
Exposed to Carbon Nanotubes and
Carbon Nanofibers—New—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–12–12RS]
mstockstill on DSK4VPTVN1PROD 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. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to Kimberly S. Lane, at 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email 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.
VerDate Mar<15>2010
16:11 Sep 19, 2012
Jkt 226001
The mission of the National Institute
for Occupational Safety and Health
(NIOSH) is to promote safety and health
at work for all people through research
and prevention. The Occupational
Safety and Health Act of 1970, Public
Law 91–596 (Section 20[a][1] authorizes
NIOSH to conduct research to advance
the health and safety of workers. In this
capacity, NIOSH will conduct an
exposure assessment and
epidemiological study of U.S. carbon
nanotube (CNT) and carbon nanofiber
(CNF) workers.
At present, because of the newness of
the technology, much of the
occupational exposure to engineered
nanomaterials occurs at the research
and development (R&D) or pilot scale.
There have been few reliable surveys of
the size of the workforce exposed to
nanomaterials. Health effects from
exposure to nanomaterials are
uncertain, but may be more severe than
from larger-sized particles of the same
material. This is due to the small size,
high surface area per unit mass (i.e.,
specific surface area) or (in some cases)
high aspect ratio of nanomaterials.
Carbon nanotubes and nanofibers are
among the nanomaterials of greatest
interest from a public health perspective
because of their potentially asbestiform
properties (e.g., high aspect ratio) and
toxicological evidence of possible
fibrogenic, inflammatory, and
clastogenic damage resulting from
exposures at occupationally relevant
levels. In addition, the useful properties
of CNT and CNF have rendered them
among the first nanomaterials to be
commercially exploited in
manufacturing settings. Thus, an
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
epidemiologic study to determine
whether early or late health effects
occur from occupational exposure to
CNT and CNF is warranted.
The proposed research is a crosssectional study of the small current U.S.
workforce involved with CNT and CNF
in manufacturing and distribution, to be
conducted in the following phases: 1)
Industrywide exposure assessment
study to evaluate worker exposure and
further develop and refine measurement
methods for CNT and CNF. This
component will refine sampling and
analysis protocols previously developed
for the detection and quantification of
CNT and CNF in US workplaces. 2) A
cross-sectional study relating the best
metrics of CNT and CNF exposure to
markers of early pulmonary or
cardiovascular health effects. After the
sampling and analysis protocols have
been established to measure CNT and
CNF, an industrywide study of the
association between exposure and
health effects will be conducted.
Medical examinations will be
conducted and several biomarkers of
early effect (for pulmonary fibrosis,
cardiovascular disease, and genetic
damage) will be measured in blood and
sputum for workers exposed to a range
of CNT and CNF levels.
The study will include a
questionnaire with a three-fold purpose:
(1) To determine whether study
participants have any contraindications
for certain medical procedures to be
conducted (spirometry and sputum
induction), (2) to assist in interpretation
of the biomarker results, and (3) to
inquire about current and past exposure
to CNT, CNF, and other chemicals,
dusts, and fumes. The questionnaire
will be given by NIOSH personnel as a
computer-assisted personal interview
(CAPI). After administration of the
CAPI, medical examinations will be
conducted to evaluate pulmonary
function (via spirometry) and blood
pressure, and sputum and blood will be
collected. Statistical analyses will be
conducted to determine the nature of
the relation between exposure to CNT
E:\FR\FM\20SEN1.SGM
20SEN1
]]>Agencies
[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58395-58396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-12RP]
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 404-639-7570 or
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS D74,
Atlanta, GA 30333 or send an email 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
Assessment of the Psychosocial Impact of Newborn Screening for
Congenital Cytomegalovirus (CMV) Infection--New--National Center for
Immunization and Respiratory Diseases (NCIRD) and National Center on
Birth Defects and Developmental Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Each year in the United States, more than 30,000 children are born
with congenital CMV infection. Approximately 80% develop normally,
while the remaining 20% are born with or subsequently develop
disabilities such as hearing loss or mental retardation. A similar
number of children are affected by serious CMV-related disabilities
than by several better-known childhood conditions, including Down
syndrome and spina bifida.
The birth prevalence of congenital CMV infection is several times
higher than the combined birth prevalence of all metabolic or endocrine
disorders in the core U.S. newborn screening panel. Because newborn CMV
screening is rarely performed, and because a definitive diagnosis of
congenital CMV requires access to urine, saliva, or blood collected
soon after birth, most infected children are never diagnosed. Newborn
CMV screening offers some clear potential benefits, but few studies
have assessed the potential for harm (e.g., increased parental anxiety,
``fragile child syndrome'').
CDC is requesting OMB approval for one year to collect information
about newborn CMV screening. The purpose of this information collection
is to understand the psychosocial impact of newborn screening on
parents whose infants underwent CMV screening as part of a routine
infant CMV screening program in Houston, Texas. The potential study
population includes approximately 70 CMV-infected children who were
symptomatic at birth, 100 CMV-infected children who were asymptomatic
at birth (20 of whom developed sequelae), and 50 controls that were
CMV-uninfected. The goals of this information collection are to: (1)
Document the positive and negative psychosocial impacts of newborn CMV
screening on parents and their children; (2) identify modifiable
factors that might increase positive psychosocial impacts and decrease
negative psychosocial impacts of newborn CMV screening; (3) use what is
learned about psychosocial impacts to identify key messages that
parents need relative to newborn CMV screening and follow-up; and (4)
to learn what challenges are associated with obtaining a congenital CMV
diagnosis in the absence of CMV newborn screening.
Much of the potential study population is unique in that their
children experienced newborn CMV screening as part of a previous
research study. Universal CMV screening has not been recommended by
medical associations or state or federal governments and as a result
newborn CMV screening is not typically performed. The parents'
experience with CMV screening and follow-up will help inform decisions
about whether newborn CMV screening would be good public health policy.
This study represents the first assessment of the experiences of
parents whose children were screened for CMV at birth.
Respondents fall into four categories depending on the past
experiences of their child who was screened for CMV:
Parent Group 1 (PG1)--Child screened positive for
congenital CMV at birth, asymptomatic at birth, but did not develop
sequelae.
Parent Group 2 (PG2)--Child screened positive for
congenital CMV at birth, asymptomatic at birth, but did subsequently
develop sequelae (e.g., hearing loss).
Parent Group 3 (PG3)--Child was diagnosed with congenital
CMV and had symptoms at birth.
Parent Group 4 (PG4)--Child screened negative for
congenital CMV at birth.
Information will be collected from PG1 via focus groups, from PG2
and PG3 via interviews, and from all four parent groups via a mail
survey. The focus group, interview and survey respondents will be asked
to participate only once. It is estimated that 71 parents will
participate in either individual interviews or focus groups and that
230 will participate in the mail survey. The interviews are planned to
take 60 minutes while the focus groups will be held for 90 minutes. The
survey is estimated to take 10 minutes per respondent to complete and
mail based on previous administrations reported in the literature.
Reading and responding to the focus group and interview recruitment
letters is estimated to take 5 minutes each. There is no cost to
respondents other than their time.
[[Page 58396]]
Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Parent category Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Parent Group 1................ Focus Group 36 1 1.5 54
Guide.
Focus group 50 1 5/60 4
recruitment
letter.
Parent Groups 2 and 3......... Interviewer 35 1 1 35
guide.
Interview 50 1 5/60 4
recruitment
letter.
Parent Groups 1, 2, 3, and 4.. Survey.......... 230 1 10/60 38
---------------------------------------------------------------
Total Burden Hours........ ................ .............. .............. .............. 135
----------------------------------------------------------------------------------------------------------------
Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012-23197 Filed 9-19-12; 8:45 am]
BILLING CODE 4163-18-P
