Agency Information Collection Activities: Proposed Collection; Comment Request, 23271-23272 [2010-10195]
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Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: April 22, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–10199 Filed 4–30–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION:
Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘National
Hospital Adverse Event Reporting
System: Questionnaire Redesign and
Testing.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3520. AHRQ invites the public to
comment on this proposed information
collection.
DATES: Comments on this notice must
he received by July 2, 2010.
Written comments should
he submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
erowe on DSK5CLS3C1PROD with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:35 Apr 30, 2010
Jkt 220001
Proposed Project
National Hospital Adverse Event
Reporting System: Questionnaire
Redesign and Testing
As provider of operational support to
the chair of the Quality Interagency
Task Force (QuIC), AHRQ coordinated
the Federal response to the Institute of
Medicine’s (IOM) 1999 report on
medical errors and outlined specific
initiatives the QuIC agencies will take.
The Errors Workgroup within the QuIC
identified the need for measures to
evaluate the use of adverse medical
event reporting for managing and
improving patient safety within
healthcare institutions. In response,
AHRQ created the Hospital Adverse
Event Reporting Survey to Provide
national estimates. This survey has been
fielded twice, first in 2005 and again in
2008.
Revisions to the questionnaire and
sample selection are now necessary in
response to the Patient Safety and
Quality Improvement Rule (Patient
Safety Rule), 42 CFR Part 3, issued by
the United States Department of Health
and Human Services, which implements
the Patient Safety and Quality
Improvement Act of 2005 (Patient Safety
Act), 42 U.S.C. 299b–21 through 299b–
26. The Patient Safety Rule and Patient
Safety Act authorize the creation of
Patient Safety Organizations (PSO) to
enhance quality and safety by collecting
patient safety reports of adverse events.
AHRQ started listing PSOs in late 2008
pursuant to the Patient Safety Act.
These organizations have begun
working with hospitals and other
providers to monitor patient safety
events according to common reporting
formats, and to improve patient safety.
This revised survey will be used for the
third round of data collection in 2011,
under a separate OMB clearance, to
assess the impact of the PSOs and the
Patient Safety Act on the use of adverse
event reporting systems and will
incorporate questions about reporting
using the AHRQ Common Formats, and
reporting information to a Patient Safety
Organization.
This project is being conducted by
AHRQ’s contractor, Westat, pursuant to
AHRQ’s statutory mandates to (I)
promote health care quality
improvement by conducting and
supporting research that develops and
presents scientific evidence regarding
all aspects of health care, including
methods for measuring quality and
strategies for improving quality (42
U.S.C. 299(b)(1)(F)) and (2) conduct and
support research on health care and on
systems for the delivery of such care,
including activities with respect to
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Fmt 4703
Sfmt 4703
23271
quality measurement and improvement
(42 U.S.C. 299a(a)(2).
Method of Collection
This project will include the
following data collections:
(1) Semi-structured interviews will be
conducted with one risk manager or
other representative responsible for
adverse event reporting from 7
participating hospitals and with one
person from the two participating PSOs.
These interviews will be conducted to
learn more about the current hospital
adverse event reporting environment
and to understand how adverse event
reporting may have changed in response
to the Patient Safety Act. Survey
developers will use the information
from these interviews to develop
questions for the revised questionnaire.
(2) Cognitive interviews will be
conducted with one risk manager or
other representative responsible for
adverse event reporting in 30
participating hospitals. The purpose of
these cognitive interviews is to test and
refine the revised questionnaire. The
questionnaire will be tested among
respondents in hospitals with no
reporting affiliation with a PSO, with
reporting affiliations with one PSO, and
with reporting affiliations with more
than one PSO.
Results from these interviews will
help inform actions by AHRQ to
encourage effective adverse event
reporting by hospitals, as part of its
patient safety initiative, including
standardization of reporting so that
consistent concepts, information, and
terminology are used in the patient
safety arena. The survey can also serve
as a baseline for changes about hospitalbased adverse event reporting to Patient
Safety Organizations and how the
Patient Safety Act might have affected
reporting structures and processes.
Estimated Annual Respondent Burden
Exhibit I shows the estimated
annualized burden hours for the
respondents time to participate in this
project. Semi-structured interviews will
be conducted with 9 persons
representing 7 hospitals and 2 PSOs and
will last for about an hour. Cognitive
interviews will be conducted with one
person in each of 30 participating
hospitals and are expected to take one
hour to complete. The total annual
burden hours are estimated to be 39
hours.
Exhibit 2 shows the estimated annual
cost burden associated with the
respondents’ time to participate in the
research. The total annual cost burden
is estimated to be $1,664.
E:\FR\FM\03MYN1.SGM
03MYN1
23272
Federal Register / Vol. 75, No. 84 / Monday, May 3, 2010 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
responding
organization
Number of
organizations
Form name
Hours per
response
Total burden
hours
Semi-structured interviews ..............................................................
Cognitive interviews .........................................................................
9
30
1
1
1
1
9
30
Total ..........................................................................................
39
NA
NA
39
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average hourly
wage rate *
Total cost burden
Semi-structured interviews ..............................................................
Cognitive interviews .........................................................................
9
30
9
30
$42.67
42.67
$384
1,280
Total ..........................................................................................
39
39
NA
1,664
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Estimated Annual Costs to the Federal
Government
government to conduct this redesign of
the Adverse Event Reporting
Questionnaire and associated sample
design. Since this project will last for
Exhibit 3 shows the estimated total
and annualized cost to the Federal
one year the total and annualized costs
are the same. The total cost is estimated
to be $120,000.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component
Total cost
Annualized cost
$24,000
46,000
26,000
24,000
$24,000
46,000
26,000
24,000
Total ..........................................................................................................................................................
erowe on DSK5CLS3C1PROD with NOTICES
Project Development .......................................................................................................................................
Data Collection Activities .................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Project Management ........................................................................................................................................
120,000
120,000
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) 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 upon the
respondents, including the use of
automated collection techniques or
other forms of in formation technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
VerDate Mar<15>2010
15:35 Apr 30, 2010
Jkt 220001
comments will become a matter of
public record.
Government-Owned Inventions;
Availability for Licensing
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
Retroviral Vectors for Selective
Reversible Immortalization of
Stimulus-responding Primary Cells
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
Description of Invention: Researchers
at the National Cancer InstituteFrederick, NIH, have developed a novel
set of retroviral vectors and producer
cell lines useful for selective reversible
immortalization of primary cells (i.e.
lymphocytes) that respond to a
stimulus, such as a viral antigen (e.g.
Dated: April 20, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–10195 Filed 4–30–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
PO 00000
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Fmt 4703
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03MYN1
]]>Agencies
[Federal Register Volume 75, Number 84 (Monday, May 3, 2010)]
[Notices]
[Pages 23271-23272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10195]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``National Hospital Adverse Event Reporting System:
Questionnaire Redesign and Testing.'' In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501-3520. AHRQ invites the public to comment
on this proposed information collection.
DATES: Comments on this notice must he received by July 2, 2010.
ADDRESSES: Written comments should he submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
National Hospital Adverse Event Reporting System: Questionnaire
Redesign and Testing
As provider of operational support to the chair of the Quality
Interagency Task Force (QuIC), AHRQ coordinated the Federal response to
the Institute of Medicine's (IOM) 1999 report on medical errors and
outlined specific initiatives the QuIC agencies will take. The Errors
Workgroup within the QuIC identified the need for measures to evaluate
the use of adverse medical event reporting for managing and improving
patient safety within healthcare institutions. In response, AHRQ
created the Hospital Adverse Event Reporting Survey to Provide national
estimates. This survey has been fielded twice, first in 2005 and again
in 2008.
Revisions to the questionnaire and sample selection are now
necessary in response to the Patient Safety and Quality Improvement
Rule (Patient Safety Rule), 42 CFR Part 3, issued by the United States
Department of Health and Human Services, which implements the Patient
Safety and Quality Improvement Act of 2005 (Patient Safety Act), 42
U.S.C. 299b-21 through 299b-26. The Patient Safety Rule and Patient
Safety Act authorize the creation of Patient Safety Organizations (PSO)
to enhance quality and safety by collecting patient safety reports of
adverse events. AHRQ started listing PSOs in late 2008 pursuant to the
Patient Safety Act. These organizations have begun working with
hospitals and other providers to monitor patient safety events
according to common reporting formats, and to improve patient safety.
This revised survey will be used for the third round of data collection
in 2011, under a separate OMB clearance, to assess the impact of the
PSOs and the Patient Safety Act on the use of adverse event reporting
systems and will incorporate questions about reporting using the AHRQ
Common Formats, and reporting information to a Patient Safety
Organization.
This project is being conducted by AHRQ's contractor, Westat,
pursuant to AHRQ's statutory mandates to (I) promote health care
quality improvement by conducting and supporting research that develops
and presents scientific evidence regarding all aspects of health care,
including methods for measuring quality and strategies for improving
quality (42 U.S.C. 299(b)(1)(F)) and (2) conduct and support research
on health care and on systems for the delivery of such care, including
activities with respect to quality measurement and improvement (42
U.S.C. 299a(a)(2).
Method of Collection
This project will include the following data collections:
(1) Semi-structured interviews will be conducted with one risk
manager or other representative responsible for adverse event reporting
from 7 participating hospitals and with one person from the two
participating PSOs. These interviews will be conducted to learn more
about the current hospital adverse event reporting environment and to
understand how adverse event reporting may have changed in response to
the Patient Safety Act. Survey developers will use the information from
these interviews to develop questions for the revised questionnaire.
(2) Cognitive interviews will be conducted with one risk manager or
other representative responsible for adverse event reporting in 30
participating hospitals. The purpose of these cognitive interviews is
to test and refine the revised questionnaire. The questionnaire will be
tested among respondents in hospitals with no reporting affiliation
with a PSO, with reporting affiliations with one PSO, and with
reporting affiliations with more than one PSO.
Results from these interviews will help inform actions by AHRQ to
encourage effective adverse event reporting by hospitals, as part of
its patient safety initiative, including standardization of reporting
so that consistent concepts, information, and terminology are used in
the patient safety arena. The survey can also serve as a baseline for
changes about hospital-based adverse event reporting to Patient Safety
Organizations and how the Patient Safety Act might have affected
reporting structures and processes.
Estimated Annual Respondent Burden
Exhibit I shows the estimated annualized burden hours for the
respondents time to participate in this project. Semi-structured
interviews will be conducted with 9 persons representing 7 hospitals
and 2 PSOs and will last for about an hour. Cognitive interviews will
be conducted with one person in each of 30 participating hospitals and
are expected to take one hour to complete. The total annual burden
hours are estimated to be 39 hours.
Exhibit 2 shows the estimated annual cost burden associated with
the respondents' time to participate in the research. The total annual
cost burden is estimated to be $1,664.
[[Page 23272]]
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Hours per Total burden
Form name organizations responding response hours
organization
----------------------------------------------------------------------------------------------------------------
Semi-structured interviews.............. 9 1 1 9
Cognitive interviews.................... 30 1 1 30
-----------------------------------------------------------------------
Total............................... 39 NA NA 39
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Semi-structured interviews.............. 9 9 $42.67 $384
Cognitive interviews.................... 30 30 42.67 1,280
-----------------------------------------------------------------------
Total............................... 39 39 NA 1,664
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States 2008, ``U.S. Department of Labor, Bureau of Labor Statistics.''
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated total and annualized cost to the
Federal government to conduct this redesign of the Adverse Event
Reporting Questionnaire and associated sample design. Since this
project will last for one year the total and annualized costs are the
same. The total cost is estimated to be $120,000.
Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
Cost component Total cost Annualized cost
------------------------------------------------------------------------
Project Development................. $24,000 $24,000
Data Collection Activities.......... 46,000 46,000
Data Processing and Analysis........ 26,000 26,000
Project Management.................. 24,000 24,000
-----------------------------------
Total........................... 120,000 120,000
------------------------------------------------------------------------
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, comments on AHRQ's information collection are requested
with regard to any of the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
AHRQ healthcare research and healthcare information dissemination
functions, including whether the information will have practical
utility; (b) the accuracy of AHRQ's estimate of burden (including hours
and costs) of the proposed collection(s) 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 upon the respondents, including the use of automated
collection techniques or other forms of in formation technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: April 20, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-10195 Filed 4-30-10; 8:45 am]
BILLING CODE 4160-90-M
