Attachment D -- Federal Register Notice

38102

Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices

objectives of the Strategic Plan. Program
staff will communicate anticipated
actions to grantees, reviewers, and
stakeholders. The staff will be open for
suggestions to improve transparency or
identify areas where clarification is
needed.
Conclusion
There remains a need for fundamental
research to address SRP’s original
mandates. The Program’s sister agencies
tasked with developing and
implementing policies to protect health
rely upon the best science. Likewise,
communities living near sites impacted
by hazardous substances need
accessible science to fully participate in
decisions made about site management.
The stated objectives of the Strategic
Plan (addressing relevant issues,
maximizing impact, and fostering
innovation) have been designed to better
address stakeholders’ needs. This
Strategic Plan, as a living document,
will guide the Program over the next
five years. Program staff look forward to
embracing this future with grantees,
stakeholders, and others who share the
greater vision of improving human
health and the environment through
reducing or eliminating the negative
impacts of exposure to hazardous
substances from hazardous waste sites.
Program staff thank the many
contributors who have provided
constructive comments during the
strategic planning process and thereby
assisted in the development of this draft
strategic plan. We are now seeking
comments on the draft strategic plan.
Comments will be accepted for 30 days
following the publication of this notice.
Please e-mail comments to
[email protected].
Dated: June 24, 2010.
William A. Suk,
Director, Center for Risk and Integrated
Sciences, Director, Superfund Research
Program, Division of Extramural Research
and Training, National Institute of
Environmental Health Sciences, National
Institutes of Health.
[FR Doc. 2010–16072 Filed 6–30–10; 8:45 am]
BILLING CODE 4140–01–P

jlentini on DSKJ8SOYB1PROD with NOTICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.

AGENCY:

VerDate Mar<15>2010

16:02 Jun 30, 2010

Jkt 220001

ACTION:

Notice.

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.
This proposed information collection
was previously published in the Federal
Register on May 3rd 2010 and allowed
60 days for public comment. One
comment was received. The purpose of
this notice is to allow an additional 30
days for public comment.
DATES: Comments on this notice must be
received by August 2, 2010.
ADDRESSES: Written comments should
be submitted to: AHRQs OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQs desk officer) or by email at [email protected]
(attention: AHRQ’s desk officer).
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:
SUMMARY:

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

PO 00000

Frm 00031

Fmt 4703

Sfmt 4703

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 (1)
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

E:\FR\FM\01JYN1.SGM

01JYN1

38103

Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Notices
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 1 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.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of organizations

Number of responses per
organization

Semi-structured interviews ..............................................................................
Cognitive interviews .........................................................................................

9
30

1
1

1
1

9
30

Total ..........................................................................................................

39

NA

NA

39

Form name

Hours per
response

Total burden
hours

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of organizations

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
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

Annualized
cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Project Management ................................................................................................................................................

$24,000
46,000
26,000
24,000

$24,000
46,000
26,000
24,000

Total ..................................................................................................................................................................

120,000

120,000

Request for Comments

jlentini on DSKJ8SOYB1PROD with NOTICES

Total cost

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

VerDate Mar<15>2010

16:02 Jun 30, 2010

Jkt 220001

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 information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent

PO 00000

Frm 00032

Fmt 4703

Sfmt 9990

request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: June 22, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–15797 Filed 6–30–10; 8:45 am]
BILLING CODE 4160–90–M

E:\FR\FM\01JYN1.SGM

01JYN1