Agency Forms Undergoing Paperwork Reduction Act Review, 49517-49519 [2014-19825]
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49517
Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Notices
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
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 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.
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 Testing in Ambulatory
Settings,’’ with continuing education
credits that is available to clinicians and
laboratorians free of charge. We would
like to ask survey respondents if they
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden
hours
Type of respondent
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 .................................
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Total ...........................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–19828 Filed 8–20–14; 8:45 am]
[30-Day–14–0212]
BILLING CODE 4163–18–P
Agency Forms Undergoing Paperwork
Reduction Act Review
Centers for Disease Control and
Prevention
The Centers for Disease Control and
Prevention (CDC) has submitted the
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following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
E:\FR\FM\21AUN1.SGM
21AUN1
49518
Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Notices
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
The National Hospital Care Survey
(NHCS) (OMB Control Number 0920–
0212; Expires 04–30–2016)—Revision—
National Center for Health Statistics
(NCHS), Centers for Disease Control and
Prevention (CDC).
mstockstill on DSK4VPTVN1PROD with NOTICES
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States. This three-year
clearance request for NHCS includes the
collection of all impatient and
ambulatory Uniform Bill-04 (UB–04)
claims data or electronic health record
(EHR) data from a sample of 581
hospitals as well as the collection of
additional clinical data from a sample of
emergency department (ED) and
outpatient department (OPD) visits
(including ambulatory surgeries)
through the abstraction of medical
records.
NHCS integrates the former National
Hospital Discharge Survey (OMB No.
0920–0212), the National Hospital
Ambulatory Medical Care Survey
(NHAMCS) (OMB No. 0920–0278) and
the Drug-Abuse Warning Network
(DAWN) (OMB No. 0930–0078, expired
12/31/2011) previously conducted by
the Substance Abuse and Mental Health
Services Administration’s (SAMHSA).
Integration of NHAMCS and DAWN into
the NHCS is part of a broader strategy
to improve efficiency by minimizing
redundancy in data collection;
broadening our capability to collect
more relevant data on transitions of
care; and identifying opportunities to
exploit electronic and administrative
clinical data systems to augment
primary data collection.
NHCS consists of a nationally
representative sample of 581 hospitals.
These hospitals are currently being
recruited, and participating hospitals
are submitting all of their inpatient and
ambulatory care patient data in the form
of electronic UB–04 administrative
claims or EHR data. Currently, hospitallevel data are collected through a paper
questionnaire and additional clinical
data are being abstracted from a sample
of visits to EDs and OPDs. This activity
continues in 2014, and as more
hospitals choose to send EHR data that
includes clinical information, the need
to conduct abstraction will be reduced.
This revision seeks approval to
continue voluntary recruitment and data
collection for NHCS, including
inpatient, outpatient and emergency
care; to revise the hospital-level
questionnaire with additional items
needed to improve weighting
procedures; to combine the OPD and
ambulatory surgery location patient
record forms to more effectively capture
ambulatory procedures in these settings;
to continue collection of substanceinvolved ED visit data previously
collected by DAWN; and to eliminate
data collection from freestanding
ambulatory surgery centers in order to
concentrate efforts on hospital-based
settings of care.
NHCS collects data items at the
hospital, patient, inpatient discharge,
and visit levels. Hospital-level data
items include ownership, number of
staffed beds, hospital service type, and
EHR adoption. Patient-level data items
are collected from both electronic data
and abstraction components and
include basic demographic information,
personal identifiers, name, address,
social security number (if available),
and medical record number (if
available). Discharge-level data are
collected through the UB–04 claims or
EHR data and include admission and
discharge dates, diagnoses, diagnostic
services, and surgical and non-surgical
procedures. Visit-level data are
collected through either EHR data, or for
those hospitals submitting UB–04
claims, through the claims as well as
through abstraction of medical records
for a sample of visits. These visit-level
data include reason for visit, diagnosis,
procedures, medications, substances
involved, and patient disposition.
NHCS users include, but are not
limited to, CDC, Congressional Research
Office, Office of the Assistant Secretary
for Planning and Evaluation (ASPE),
National Institutes of Health, American
Health Care Association, Centers for
Medicare & Medicaid Services (CMS),
SAMHSA, Bureau of the Census, Office
of National Drug Control Policy, state
and local governments, and nonprofit
organizations. Other users of these data
include universities, research
organizations, many in the private
sector, foundations, and a variety of
users in the media.
Data collected through NHCS are
essential for evaluating health status of
the population, for the planning of
programs and policy to improve health
care delivery systems of the Nation, for
studying morbidity trends, and for
research activities in the health field.
Historically, data have been used
extensively in the development and
monitoring of goals for the Year 2000,
2010, and 2020 Healthy People
Objectives.
There is no cost to respondents other
than their time to participate. The total
burden is 8,232 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Hospital DHIM or DHIT ..................................
Hospital CEO/CFO .........................................
Initial Hospital Intake Questionnaire .............
Recruitment Survey Presentation .................
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Number of
responses per
respondent
Avgerage
burden per
response
(in hrs)
1
1
1
1
160
160
21AUN1
49519
Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Hospital DHIM or DHIT ..................................
Hospital CEO/CFO .........................................
Hospital CEO/CFO .........................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–19825 Filed 8–20–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–14–0913]
mstockstill on DSK4VPTVN1PROD with NOTICES
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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;(d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
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17:18 Aug 20, 2014
Jkt 232001
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Evaluating Locally-Developed HIV
Prevention Interventions for AfricanAmerican MSM in Los Angeles (OMB
Control No. 0920–0913, expires 01/15/
2015)—Extension — National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Data on HIV cases reported in 33 U.S.
states with HIV reporting indicate the
burden of HIV/AIDS is most
concentrated in the African-American
population compared to other racial/
ethnic groups. Of the 49,704 AfricanAmerican males diagnosed with HIV
between 2001 and 2004, 54% of these
cases were among men who have sex
with men (MSM). In Los Angeles
County (LAC), the proportion of HIV/
AIDS cases among African-American
males attributable to male-to-male
sexual transmission is even greater
(75%).
In the absence of an effective vaccine,
behavioral interventions represent one
of the few methods for reducing high
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Avgerage
burden per
response
(in hrs)
481
12
1
100
4
1
581
385
Prepare and transmit UB–04 for Inpatient
and Ambulatory.
Prepare and transmit EHR for Inpatient and
Ambulatory.
Annual Hospital Interview .............................
Annual Ambulatory Hospital Interview ..........
Hospital DHIM or DHIT ..................................
Number of
responses per
respondent
1
1
2
1.5
Number of
respondents
Type of respondents
HIV incidence among African American
MSM (AAMSM). Unfortunately, in the
third decade of the epidemic, very few
of the available HIV-prevention
interventions for African-American
populations have been designed
specifically for MSM. In fact, until very
recently, none of CDC’s evidence-based
HIV-prevention interventions had been
specifically tested for efficacy in
reducing HIV transmission among MSM
of color. Given the conspicuous absence
of (1) evidence-based HIV interventions
and (2) outcome evaluations of existing
AAMSM interventions, our
collaborative team intends to address a
glaring research gap by implementing a
best-practices model of comprehensive
program evaluation.
The purpose of this project is to test,
in a real-world setting, the efficacy of an
HIV transmission prevention
intervention for reducing sexual risk
among African-American men who have
sex with men in Los Angeles County.
The intervention is a three-session,
group-level intervention that will
provide participants with the
information, motivation, and skills
necessary to reduce their risk of
transmitting or acquiring HIV.
The intervention is being evaluated
using baseline, 3-month and 6-month
follow up assessments. This project also
intends to conduct in-depth qualitative
interviews with a total of 36 men in
order to assess the experiences with the
intervention, elicit recommendations for
improving the intervention, and to
better understand the factors that place
young African American MSM at risk
for HIV.
CDC is requesting approval for a 1year clearance to complete data
collection. The data collection system
involves screenings, limited locator
information, contact information,
baseline questionnaire, client
satisfaction surveys, 3-month follow-up
questionnaire, 6-month follow-up
questionnaire, and case study
interviews.
An estimated 160 men will be
screened for eligibility in order to enroll
80 additional men to reach the desired
E:\FR\FM\21AUN1.SGM
21AUN1
]]>Agencies
[Federal Register Volume 79, Number 162 (Thursday, August 21, 2014)]
[Notices]
[Pages 49517-49519]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-14-0212]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your
[[Page 49518]]
comments should address any of the following: (a) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (b) Evaluate the accuracy of
the agencies estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (c) Enhance the quality, utility, and clarity of the information
to be collected; (d) Minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses; and (e) Assess
information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
The National Hospital Care Survey (NHCS) (OMB Control Number 0920-
0212; Expires 04-30-2016)--Revision--National Center for Health
Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall collect statistics on the
extent and nature of illness and disability of the population of the
United States. This three-year clearance request for NHCS includes the
collection of all impatient and ambulatory Uniform Bill-04 (UB-04)
claims data or electronic health record (EHR) data from a sample of 581
hospitals as well as the collection of additional clinical data from a
sample of emergency department (ED) and outpatient department (OPD)
visits (including ambulatory surgeries) through the abstraction of
medical records.
NHCS integrates the former National Hospital Discharge Survey (OMB
No. 0920-0212), the National Hospital Ambulatory Medical Care Survey
(NHAMCS) (OMB No. 0920-0278) and the Drug-Abuse Warning Network (DAWN)
(OMB No. 0930-0078, expired 12/31/2011) previously conducted by the
Substance Abuse and Mental Health Services Administration's (SAMHSA).
Integration of NHAMCS and DAWN into the NHCS is part of a broader
strategy to improve efficiency by minimizing redundancy in data
collection; broadening our capability to collect more relevant data on
transitions of care; and identifying opportunities to exploit
electronic and administrative clinical data systems to augment primary
data collection.
NHCS consists of a nationally representative sample of 581
hospitals. These hospitals are currently being recruited, and
participating hospitals are submitting all of their inpatient and
ambulatory care patient data in the form of electronic UB-04
administrative claims or EHR data. Currently, hospital-level data are
collected through a paper questionnaire and additional clinical data
are being abstracted from a sample of visits to EDs and OPDs. This
activity continues in 2014, and as more hospitals choose to send EHR
data that includes clinical information, the need to conduct
abstraction will be reduced.
This revision seeks approval to continue voluntary recruitment and
data collection for NHCS, including inpatient, outpatient and emergency
care; to revise the hospital-level questionnaire with additional items
needed to improve weighting procedures; to combine the OPD and
ambulatory surgery location patient record forms to more effectively
capture ambulatory procedures in these settings; to continue collection
of substance-involved ED visit data previously collected by DAWN; and
to eliminate data collection from freestanding ambulatory surgery
centers in order to concentrate efforts on hospital-based settings of
care.
NHCS collects data items at the hospital, patient, inpatient
discharge, and visit levels. Hospital-level data items include
ownership, number of staffed beds, hospital service type, and EHR
adoption. Patient-level data items are collected from both electronic
data and abstraction components and include basic demographic
information, personal identifiers, name, address, social security
number (if available), and medical record number (if available).
Discharge-level data are collected through the UB-04 claims or EHR data
and include admission and discharge dates, diagnoses, diagnostic
services, and surgical and non-surgical procedures. Visit-level data
are collected through either EHR data, or for those hospitals
submitting UB-04 claims, through the claims as well as through
abstraction of medical records for a sample of visits. These visit-
level data include reason for visit, diagnosis, procedures,
medications, substances involved, and patient disposition.
NHCS users include, but are not limited to, CDC, Congressional
Research Office, Office of the Assistant Secretary for Planning and
Evaluation (ASPE), National Institutes of Health, American Health Care
Association, Centers for Medicare & Medicaid Services (CMS), SAMHSA,
Bureau of the Census, Office of National Drug Control Policy, state and
local governments, and nonprofit organizations. Other users of these
data include universities, research organizations, many in the private
sector, foundations, and a variety of users in the media.
Data collected through NHCS are essential for evaluating health
status of the population, for the planning of programs and policy to
improve health care delivery systems of the Nation, for studying
morbidity trends, and for research activities in the health field.
Historically, data have been used extensively in the development and
monitoring of goals for the Year 2000, 2010, and 2020 Healthy People
Objectives.
There is no cost to respondents other than their time to
participate. The total burden is 8,232 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Avgerage
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hrs)
----------------------------------------------------------------------------------------------------------------
Hospital DHIM or DHIT................ Initial Hospital Intake 160 1 1
Questionnaire.
Hospital CEO/CFO..................... Recruitment Survey 160 1 1
Presentation.
[[Page 49519]]
Hospital DHIM or DHIT................ Prepare and transmit UB- 481 12 1
04 for Inpatient and
Ambulatory.
Hospital DHIM or DHIT................ Prepare and transmit EHR 100 4 1
for Inpatient and
Ambulatory.
Hospital CEO/CFO..................... Annual Hospital 581 1 2
Interview.
Hospital CEO/CFO..................... Annual Ambulatory 385 1 1.5
Hospital Interview.
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-19825 Filed 8-20-14; 8:45 am]
BILLING CODE 4163-18-P
