Proposed Data Collections Submitted for Public Comment and Recommendations, 20112-20114 [2013-07742]
Download as PDF
<![CDATA[
20112
Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices
To this end, CDC will identify and
recruit 3 ROR pediatric practices and 3
non-ROR practices in the greater
Atlanta, Georgia and greater
Washington, DC areas to distribute
copies of Amazing Me to parents/
guardians of 3-year-olds, soon to be 3year-olds, or recently turned 4-year-olds
attending the selected practices. The
study will gather feedback from parents/
guardians about (1) their experiences
receiving the book as part of a pediatric
visit, and (2) the influence of the book
on their awareness, attitudes, and selfefficacy regarding monitoring
developmental milestones. Data will be
gathered through a web survey of 900
parents/guardians who have received a
copy of the Amazing Me book from
participating ROR and non-ROR
practices. Parents/guardians will access
the web survey by logging onto a URL
address provided on a sticker affixed to
the inside cover of each Amazing Me
book. We estimate that we will screen
900 parents/guardians in order to recruit
900 respondents for the web survey.
CDC will also conduct six follow-up
focus groups with survey respondents to
gather more in-depth information from
parents about their experiences reading
the Amazing Me book at home with
their children and assessing their child’s
development using the book. We
estimate that we will screen 60 parents/
guardians to recruit 54 participants for
the focus groups. These six focus groups
will be conducted in greater Atlanta,
Georgia and greater Washington, DC.
Findings from the parent web survey
and focus groups will help CDC to
determine if a children’s book is an
effective channel for reaching parents,
whether more books like Amazing Me
for other age groups should be
developed, and if the ROR book
distribution model is an effective means
to reach low-income and at-risk
families.
This request is submitted to obtain
Office of Management and Budget
(OMB) clearance for two years. The
estimated annualized burden hours for
this data collection activity are 139.
There are no costs to the respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Web Survey
Parents/Guardians ............................
Parents/Guardians ............................
Web Screener and Survey ...............
Follow-up Contact Survey ................
900
900
1
1
4/60
1/60
60
15
60
54
54
1
1
1
5/60
5/60
1
5
5
54
Focus Groups
Parents/Guardians ............................
Parents/Guardians ............................
Parents/Guardians ............................
Screener ...........................................
Informed Consent .............................
Focus Group Moderator’s Guide .....
Total ...........................................
139
Dated: March 28, 2013.
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. 2013–07744 Filed 4–2–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–0924]
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
VerDate Mar<15>2010
17:13 Apr 02, 2013
Jkt 229001
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 or send
comments to Ron Otten, 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
Survey of Rapid Influenza Diagnostic
Test (RIDT) Practices in Clinical
Laboratories and Evaluation of
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Laboratory Course—Reinstatement
(OMB Control No. 0920–0924) with
change—the Office of Surveillance,
Epidemiology, and Laboratory Services
(OSELS), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The purpose of this request is to
obtain Office of Budget and
Management (OMB) approval to
reinstate with change, the data
collection for the Survey of Rapid
Influenza Diagnostic Test (RIDT)
Practices in Clinical Laboratories (OMB
Control No. 0920–0924). OMB approval
for the 2012 RIDT project expired
February 28, 2012. CDC seeks a threeyear approval to conduct the RIDT
project. Changes incorporated into this
reinstatement request include changing
the name of the collection to ‘‘Survey of
Rapid Influenza Diagnostic Test (RIDT)
Practices in Clinical Laboratories and
Evaluation of Laboratory Course’’ and
adding a question about whether or not
the participants have taken the free CDC
rapid influenza testing course, Strategies
for Improving Rapid Influenza Testing
E:\FR\FM\03APN1.SGM
03APN1
20113
Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices
in Ambulatory Settings, and to rate the
usefulness of the course in their clinical
setting. The Survey of Rapid Influenza
Diagnostic Testing Practices in Clinical
Laboratories and Evaluation of
Laboratory Course is a national
systematic study investigating rapid
influenza diagnostic testing practices in
clinical laboratories. The survey will be
funded in full by the Office of
Surveillance, Epidemiology, and
Laboratory Services of the Centers for
Disease Control and Prevention.
Influenza epidemics usually cause an
average more than 200,000
hospitalizations and 36,000 deaths per
year in the U.S. Respiratory illnesses
caused by influenza viruses are not
easily differentiated from other
respiratory infections based solely on
symptoms. Also influenza viruses may
adversely affect different
subpopulations.
The effective use of rapid influenza
diagnostic testing practices is an
important component of the differential
diagnosis of influenza-like-illness in
both inpatient and outpatient treatment
facilities. Test results are used for
making decisions about antiviral versus
antibiotic use, and in making admission
or discharge decisions. In many cases,
rapid influenza tests are the only tests
that can provide results while the
patient is still present in the facility.
Thus, the appropriate use of the tests,
and interpretation of test results is
critical to the treatment and control of
influenza. More than a dozen rapid tests
have been approved by the U.S. Food
and Drug Administration and are in
Influenza Diagnostic Testing’’, with
continuing education credits that is
available to clinicians and laboratorians
free of charge. We would like to ask
respondents to the survey if they have
taken the course, and ask them to rate
its usefulness.
The survey covers basic laboratory
demographic characteristics, specimen
collection and processing, testing
practices, reporting of results to
emergency departments and other
treatment facilities, reporting results to
health departments, quality assurance
practices, and methods of receiving
updated influenza-related information.
The respondents would be clinical
laboratory supervisors, nurses, and
other clinicians. The majority of the
questions request information about
laboratory influenza testing practices.
For this request, we have also added a
question about whether or not the
participants have taken the free CDC
rapid influenza testing course and to
rate its usefulness in their clinical
setting.
No updated systematic study has been
conducted to investigate how
laboratories now use these tests, how
they report results, or how they interact
with outpatient treatment facilities,
whether they have taken the free rapid
influenza testing course, or how they
rate the course. The survey will be
conducted on a national sample of
laboratories and clinical facilities,
including those in outpatient facilities
that perform rapid influenza diagnostic
tests. There are no costs to respondents
except their time.
widespread use. The reliability of rapid
influenza tests is influenced by the
individual test product used and the
setting. Reported sensitivities range
from 10–75%; while the median
specificities reported are 90–95%. Other
factors influencing accuracy are the
stage (or duration) of illness when the
diagnostic specimen is collected, type
and adequacy of the specimen collected,
variability in user technique for
specimen collection or assay
performance, and disease activity in the
community. Given these and other
collective findings, it is imperative for
public health and for response planning
that CDC develops sector-specific
guidance and effective outreach to the
clinicians on appropriate use of RIDT in
their practices.
Previous studies by CDC of outpatient
facilities showed that clinical
laboratories usually perform the rapid
tests for emergency departments, and
provide results for both inpatient and
outpatient treatment. Thus,
understanding the use of rapid
influenza testing in clinical laboratories
in both hospitals and outpatient
settings, how the results are reported to
emergency departments, treatment
facilities and health departments, and
what quality assurance practices are
used will guide future efforts of the CDC
to continue to develop and update
appropriate influenza testing guidelines
and sector-specific training materials for
clinicians and improve health outcomes
of the American public. In fact, CDC has
developed a rapid testing course,
‘‘Strategies for Improving Rapid
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hrs)
Total burden
(in hrs)
Type of respondents
Form name
Clinical Laboratory Supervisors ........
Survey of Rapid Influenza Diagnostic Test Practices in Clinical
Laboratories.
Survey of Rapid Influenza Diagnostic Test Practices in Clinical
Laboratories.
Survey of Rapid Influenza Diagnostic Test Practices in Clinical
Laboratories.
600
1
30/60
300
600
1
30/60
300
600
1
30/60
300
...........................................................
........................
........................
........................
900
Nurses ...............................................
Other Clinicians .................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Total ...........................................
VerDate Mar<15>2010
17:13 Apr 02, 2013
Jkt 229001
PO 00000
Frm 00027
Fmt 4703
Sfmt 9990
E:\FR\FM\03APN1.SGM
03APN1
20114
Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices
Dated: March 28, 2013.
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. 2013–07742 Filed 4–2–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–13PQ]
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 Ron Otten, 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
Proposed Project
DELTA FOCUS Program Evaluation—
New—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Intimate Partner Violence (IPV) is a
serious, preventable public health
VerDate Mar<15>2010
17:13 Apr 02, 2013
Jkt 229001
problem that affects millions of
Americans and results in serious
consequences for victims, families, and
communities. IPV occurs between two
people in a close relationship. The term
‘‘intimate partner’’ describes physical,
sexual, or psychological harm by a
current or former partner or spouse. IPV
can impact health in many ways,
including long-term health problems,
emotional impacts, and links to negative
health behaviors. IPV exists along a
continuum from a single episode of
violence to ongoing battering; many
victims do not report IPV to police,
friends, or family.
Primary prevention means stopping
IPV before it occurs. In 2002, authorized
by the Family Violence Prevention
Services Act (FVPSA), CDC developed
the Domestic Violence Prevention
Enhancements and Leadership Through
Alliances (DELTA) Program, with a
focus on the primary prevention of IPV.
Since that time, The DELTA Program
has funded state domestic violence
coalitions (SDVCs) to engage in
statewide primary prevention efforts
and to provide training, technical
assistance, and financial support to
local communities for local primary
prevention efforts. DELTA FOCUS
(Domestic Violence Prevention
Enhancement and Leadership through
Alliances, Focusing on Outcomes for
Communities United with States) builds
on that history by providing focused
funding to states and communities for
intensive implementation and
evaluation of IPV primary prevention
strategies that address the structural
determinants of health at the societal
and community levels of the socialecological model (SEM).
The purpose of the DELTA FOCUS
program is to promote the prevention of
IPV through the implementation and
evaluation of strategies that create a
foundation for the development of
practice-based evidence. By
emphasizing primary prevention, this
program will support comprehensive
and coordinated approaches to IPV
prevention. Each SDVC is required to
identify and fund one to two wellorganized, broad-based, active local
coalitions (referred to as coordinated
community responses or CCRs) that are
already engaging in, or are at capacity to
engage in, IPV primary prevention
strategies affecting the structural
determinants of health at the societal
and/or community levels of the SEM.
SDVCs must facilitate and support local-
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
level implementation and hire
empowerment evaluators to support the
evaluation of IPV prevention strategies
by the CCRs. SDVCs must also
implement and with their
empowerment evaluators, evaluate
state-level IPV prevention strategies.
CDC seeks OMB approval to collect
information electronically from
awardees, their CCRs and their
empowerment evaluators. Information
will be collected using the DELTA
FOCUS Program Evaluation Survey
(referred to as DF Survey). The DF
survey will collect information about
SDVCs satisfaction with CDC efforts to
support them; process, program and
strategy implementation factors that
affect their ability to meet the
requirements of the Funding
Opportunity Announcement (FOA);
prevention knowledge and use of the
public health approach; and
sustainability of prevention activities
and successes.
Information collected through the DF
Survey will be used to guide program
improvements by CDC in the national
DELTA FOCUS program
implementation and program
improvements by SDVCs in
implementation of the program within
their state. Specifically the data
collection will allow the federal
government to assess: a) opportunities
and barriers to implementing the
DELTA FOCUS program at the state and
local levels, b) benefits and challenges
of focusing on prevention strategies at
the societal and community levels, and
c) what data informed program
improvements are needed. Not
collecting this data could result in
inappropriate implementation at the
national, state, and local levels. Thus,
this data collection is an essential
program evaluation activity.
The DF Survey will be completed by
10 SDVC executive directors, 10 SDVC
project coordinators, 19 CCR project
coordinators, and 10 SDVC
empowerment evaluators and take a
maximum of 1 hour to complete. We
expect for each SDVC there will be four
web-based surveys completed in the
first year (2013) of awardee activity.
CDC will analyze, interpret, translate,
and disseminate the survey findings in
years two and three of the information
collection request. The total estimated
annualized burden for the proposed 10
awardees is 44 hours. There are no costs
to respondents other than their time.
E:\FR\FM\03APN1.SGM
03APN1
]]>Agencies
[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20112-20114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07742]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-0924]
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 or
send comments to Ron Otten, 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
Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in
Clinical Laboratories and Evaluation of Laboratory Course--
Reinstatement (OMB Control No. 0920-0924) with change--the Office of
Surveillance, Epidemiology, and Laboratory Services (OSELS), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this request is to obtain Office of Budget and
Management (OMB) approval to reinstate with change, the data collection
for the Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in
Clinical Laboratories (OMB Control No. 0920-0924). OMB approval for the
2012 RIDT project expired February 28, 2012. CDC seeks a three-year
approval to conduct the RIDT project. Changes incorporated into this
reinstatement request include changing the name of the collection to
``Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in
Clinical Laboratories and Evaluation of Laboratory Course'' and adding
a question about whether or not the participants have taken the free
CDC rapid influenza testing course, Strategies for Improving Rapid
Influenza Testing
[[Page 20113]]
in Ambulatory Settings, and to rate the usefulness of the course in
their clinical setting. The Survey of Rapid Influenza Diagnostic
Testing Practices in Clinical Laboratories and Evaluation of Laboratory
Course is a national systematic study investigating rapid influenza
diagnostic testing practices in clinical laboratories. The survey will
be funded in full by the Office of Surveillance, Epidemiology, and
Laboratory Services of the Centers for Disease Control and Prevention.
Influenza epidemics usually cause an average more than 200,000
hospitalizations and 36,000 deaths per year in the U.S. Respiratory
illnesses caused by influenza viruses are not easily differentiated
from other respiratory infections based solely on symptoms. Also
influenza viruses may adversely affect different subpopulations.
The effective use of rapid influenza diagnostic testing practices
is an important component of the differential diagnosis of influenza-
like-illness in both inpatient and outpatient treatment facilities.
Test results are used for making decisions about antiviral versus
antibiotic use, and in making admission or discharge decisions. In many
cases, rapid influenza tests are the only tests that can provide
results while the patient is still present in the facility. Thus, the
appropriate use of the tests, and interpretation of test results is
critical to the treatment and control of influenza. More than a dozen
rapid tests have been approved by the U.S. Food and Drug Administration
and are in widespread use. The reliability of rapid influenza tests is
influenced by the individual test product used and the setting.
Reported sensitivities range from 10-75%; while the median
specificities reported are 90-95%. Other factors influencing accuracy
are the stage (or duration) of illness when the diagnostic specimen is
collected, type and adequacy of the specimen collected, variability in
user technique for specimen collection or assay performance, and
disease activity in the community. Given these and other collective
findings, it is imperative for public health and for response planning
that CDC develops sector-specific guidance and effective outreach to
the clinicians on appropriate use of RIDT in their practices.
Previous studies by CDC of outpatient facilities showed that
clinical laboratories usually perform the rapid tests for emergency
departments, and provide results for both inpatient and outpatient
treatment. Thus, understanding the use of rapid influenza testing in
clinical laboratories in both hospitals and outpatient settings, how
the results are reported to emergency departments, treatment facilities
and health departments, and what quality assurance practices are used
will guide future efforts of the CDC to continue to develop and update
appropriate influenza testing guidelines and sector-specific training
materials for clinicians and improve health outcomes of the American
public. In fact, CDC has developed a rapid testing course, ``Strategies
for Improving Rapid Influenza Diagnostic Testing'', with continuing
education credits that is available to clinicians and laboratorians
free of charge. We would like to ask respondents to the survey if they
have taken the course, and ask them to rate its usefulness.
The survey covers basic laboratory demographic characteristics,
specimen collection and processing, testing practices, reporting of
results to emergency departments and other treatment facilities,
reporting results to health departments, quality assurance practices,
and methods of receiving updated influenza-related information. The
respondents would be clinical laboratory supervisors, nurses, and other
clinicians. The majority of the questions request information about
laboratory influenza testing practices. For this request, we have also
added a question about whether or not the participants have taken the
free CDC rapid influenza testing course and to rate its usefulness in
their clinical setting.
No updated systematic study has been conducted to investigate how
laboratories now use these tests, how they report results, or how they
interact with outpatient treatment facilities, whether they have taken
the free rapid influenza testing course, or how they rate the course.
The survey will be conducted on a national sample of laboratories and
clinical facilities, including those in outpatient facilities that
perform rapid influenza diagnostic tests. There are no costs to
respondents except their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hrs)
respondent hrs)
----------------------------------------------------------------------------------------------------------------
Clinical Laboratory Survey of Rapid 600 1 30/60 300
Supervisors. Influenza
Diagnostic Test
Practices in
Clinical
Laboratories.
Nurses........................ Survey of Rapid 600 1 30/60 300
Influenza
Diagnostic Test
Practices in
Clinical
Laboratories.
Other Clinicians.............. Survey of Rapid 600 1 30/60 300
Influenza
Diagnostic Test
Practices in
Clinical
Laboratories.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 900
----------------------------------------------------------------------------------------------------------------
[[Page 20114]]
Dated: March 28, 2013.
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. 2013-07742 Filed 4-2-13; 8:45 am]
BILLING CODE 4163-18-P
