Attachment H -- Federal Register Notice

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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / 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.
ACTION: Notice.
AGENCY:

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:
‘‘Standardizing Antibiotic Use in Longterm Care Settings.’’ 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 November 15th, 2010 and
allowed 60 days for public comment. No
comments were 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 February 25, 2011.
ADDRESSES: Written comments should
be submitted to: AHRQ’s 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
[email protected].
SUMMARY:

SUPPLEMENTARY INFORMATION:

Proposed Project

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Standardizing Antibiotic Use in Longterm Care Settings
This project seeks to contribute to
AHRQ’s mission by optimizing
antibiotic prescribing practices in
nursing homes. Nursing homes serve as
one of our most fertile breeding grounds
for antibiotic-resistant strains of
bacteria. Nursing home residents, with
their combination of the effects of
normal aging and multiple chronic
diseases, have relatively high rates of
infection. With high rates of respiratory,
urinary, skin, and other infection comes

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a very high rate of antibiotic use that
gives rise to Methicillin-resistant
Staphylococcus aureus (MRSA),
Vancomycin-resistant Enterococci
(VRE), fluoroquinolone-resistant strains
of a variety of bacteria, and multi-drug
resistant organisms (MDROs).
Inappropriate antibiotic prescribing
practices by primary care clinicians
caring for residents in long-term care
(LTC) communities is becoming a major
public health concern. Antibiotics are
among the most commonly prescribed
pharmaceuticals in LTC settings, yet
reports indicate that a high proportion
of antibiotic prescriptions are
inappropriate.
In an effort to reduce antibiotic
overprescribing, Loeb and colleagues
developed minimum criteria for the
initiation of antibiotics in LTC setting.
The criteria have been tested in several
studies, but their implementation and
tests of validity have been limited. In
particular, though Loeb and colleagues
developed distinct minimum criteria for
several types of infection (skin and softtissue, respiratory, urinary tract, and
unexplained fever), a rigorous
evaluation has been conducted only for
urinary tract infections.
This project will assess an approach
to using the Loeb criteria that requires
minimal changes in facility procedures
and, therefore, is likely to be widely
adopted by nursing homes. The
intervention makes use of a
Communication and Order Form (COF),
which has been designed by the
researchers and will be used by the
nurses and physicians to guide their
decision-making about whether to order
an antibiotic for a specific resident
experiencing a specific infection.
Twelve nursing homes will
participate in this project with eight
assigned to the intervention and four
serving as controls. The eight
intervention sites will be divided into
two groups of four sites each, with one
group receiving an additional follow-up
training 2 months after the intervention.
The objectives of the study are to:
1. Implement a quality improvement
(QI) intervention program to optimize
antibiotic prescribing practices;
2. Evaluate the effect of the QI
intervention on antibiotic prescribing
practices including validation of the
Loeb minimum criteria; and
3. Develop and execute a
dissemination plan to ensure wide
dissemination of the findings and
recommendations for improving
antibiotic prescribing behaviors in LTC
settings.
This study is being conducted by
AHRQ through its contractor, the
American Institutes for Research (AIR),

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pursuant to AHRQ’s statutory authority
to conduct and support research on
healthcare and on systems for the
delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness, and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
The following data collection
activities and trainings will be
implemented to achieve the first two
objectives of this project:
1. Loeb Criteria Communication and
Order Form—This form will be
completed by staff in the eight
intervention nursing homes to
determine if the Loeb criteria have been
met. The COF provides a logical
decision model for determining the
need for an antibiotic. Facility staff will
complete the paper form and the data
from the forms will be entered into a
database by the project researchers.
Based on a preliminary review of the
infection logs at 4 nursing homes, we
estimate that staff nurses will complete
an average of 17 COFs per month per
nursing home at the 8 nursing homes
that will use the COF during the 6month intervention period.
2. Medical record reviews (MMR)—To
be conducted by research staff to collect
outcome data to determine antibiotic
prescribing practices and their effects
and to assess the resident’s health and
functional status, which are potentially
important control variables. Outcome
and control variables will be obtained
by monthly chart review and review of
the Nursing Home Minimum Data Set
(MDS) for a period of 9 months: Three
months preceding the initiation of the
QI intervention (for which the charts of
all eligible residents will be abstracted
for a 3 month period at one time), and
every other month during a 6-month
period following the inception of the
intervention (for which the charts of all
eligible residents will be abstracted for
the preceding two months) AHRQ’s
contractor will conduct the data
abstraction at all 12 facilities (treatment
and control). Since this data collection
will not impose a burden on the facility
staff, OMB clearance is not required.
3. Staff training—Prior to
implementation, the staff
(administrators, nurses, and physicians)
at all eight intervention sites will be
trained in the proper use of the Loeb
Criteria COF. Staff at four of the
intervention sites will be trained a
second time 2 months after the initial
training. We estimate that an average of

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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices
24 nurses and 2 physicians will be
trained at each nursing home.
4. Pre-implementation semistructured interview—The purpose of
this interview is to gain an
understanding of (1) how the staff and
the department(s) and/or wider facility
perceive quality improvement, in
general; (2) the amount of experience
the site has in QI and its processes for
handling infections; (3) why the facility
decided to adopt the Loeb Criteria COF;
and (4) the facility’s goals for the Loeb
Criteria COP implementation. Four staff
members will be interviewed at each
nursing home: Two champions (likely
the administrator, director of nursing,
and/or the assistant director of nursing),
one line nurse, and one staff physician.
Questions vary by respondent type.
5. Post-training semi-structured
interview—The purpose of this
interview is to measure the staff’s
(1) perceived adequacy of the training;
(2) their reactions to the training; and (3)
their plans for implementation. The
same four persons at each nursing home
who were interviewed for the preimplementation semi-structured

interviews will participate in this
interview. Questions vary by respondent
type.
6. Post-implementation semistructured interview—The purpose of
this interview is to identify
(1) facilitators and barriers to
implementation; (2) how barriers were
overcome; (3) what barriers remain;
(4) perceived impacts of the Loeb
Criteria COP on the use of antibiotics
within the facility; and (5) the facility’s
view on the business case for Loeb
Criteria COP. The same four persons at
each nursing home who participated in
the previous semi-structured interviews
will participate in this interview.
Questions do not vary by respondent
type.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours the nursing
homes’ time to participate in this
project. All of the data collections and
training in Exhibit 1 pertain only to the
eight intervention nursing homes. The
Loeb Criteria COF will be completed
approximately 17 times a month for 6

months (102 total) by staff at each
nursing home and will require about 5
minutes to complete. Staff training will
be attended by all nursing and medical
staff members at each nursing home (an
average of 24 nurses and two physicians
per facility) and will last 1 hour. All
eight intervention facilities will receive
training once at the start of the
intervention and four of the eight
facilities will receive a second training
one month later to see if reinforcement
results in improved performance. The
pre-implementation, post training and
post-implementation semi structured
interviews will be completed by the
same four staff members at each nursing
home consisting of two champions
(likely the administrator, director of
nursing, and/or the assistant director of
nursing), one line nurse, and one staff
physician. Each interview will be
scheduled for 1 hour. The total annual
burden is estimated to be 476 hours.
Exhibit 2 shows the estimated annual
cost burden associated with the
respondents’ time to participate in this
project. The total annual cost burden is
estimated to be $17,508.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Number of
nursing homes

Number of
responses per
nursing home

Hours per
response

Total burden
hours

Loeb Criteria COF ...........................................................................................
Staff training .....................................................................................................
Initial Training ..................................................................................................
Re-training .......................................................................................................
Pre-implementation semi-structured interview .................................................
Post training semi-structured interview ............................................................
Post-implementation semi-structured interview ...............................................

8

102

5/60

68

8
4
8
8
8

26
26
4
4
4

1
1
1
1
1

208
104
32
32
32

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

44

na

na

476

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
nursing homes

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Form name

Total burden
hours

Average hourly wage rate *

Total cost
burden

Loeb Criteria COF ...........................................................................................
Staff training .....................................................................................................
Initial Training ..................................................................................................
Re-training .......................................................................................................
Pre-implementation semi-structured interview .................................................
Post training semi-structured interview ............................................................
Post-implementation semi-structured interview ...............................................

8

68

$33

$2,244

8
4
8
8
8

208
104
32
32
32

36
36
42
42
42

7,488
3,744
1,344
1,344
1,344

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

44

476

na

17,508

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2009, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ $33 is the average wage for nurses who will complete the COF. $36 is the weighted average
wage of 24 nurses at $33 per hour and 2 physicians at $70 per hour who will be trained. $42 is the weighted average wage of 3 nurses and administrators at $33 per hour and 1 physician at $70 per hour who will be interviewed.

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annual cost to the government for

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funding this project. Although data
collection will require less than one
year, the entire project will span 2 years.

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The total cost of this research is
estimated to be $999,554.

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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Total cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................

$103,498
361,178
193,830
48,497
65,334
227,217

$51,749
180,589
96,915
24,249
32,667
113,609

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

999,554

499,777

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 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: January 11, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–1540 Filed 1–25–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 1 p.m.–3 p.m., March 9,
2011 (Closed).
Place: National Institute for Occupational
Safety and Health (NIOSH), CDC, 1095
Willowdale Road, Morgantown, West
Virginia 26506, telephone: (304) 285–6143.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the initial review, discussion, and
evaluation of ‘‘Member Conflict Review, PA
07–318.’’
Contact Person for More Information: M.
Chris Langub, PhD, Scientific Review Officer,
Office of Extramural Programs, National
Institute for Occupational Safety and Health,
CDC, 1600 Clifton Road, NE., Mailstop E74,
Atlanta, Georgia 30333; Telephone: (404)
498–2543.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dated: January 17, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–1615 Filed 1–25–11; 8:45 am]
BILLING CODE 4163–18–P

Centers for Disease Control and
Prevention

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Annualized
cost

Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Member
Conflict Review, Program
Announcement (PA) 07–318, Initial
Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Cooperative
Agreement Program for the National
Academic Centers of Excellence in
Youth Violence Prevention (U01),
Funding Opportunity Announcement
(FOA) CE10–004, Initial Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) announce
the following meeting of the
aforementioned meeting:
Times and Dates:
8 a.m.–5 p.m., February 17, 2011 (Closed).
8 a.m.–5 p.m., February 18, 2011 (Closed).
Place: Atlanta Marriot Marquis Hotel, 265
Peachtree Center Avenue, Atlanta, Georgia
30303, Telephone: (404) 521–0000.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5,
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Section 10(d) of Public Law
92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to ‘‘Cooperative Agreement Program
for the National Academic Centers of
Excellence in Youth Violence Prevention
(U01), FOA CE10–004, initial review’’.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: J.
Felix Rogers, PhD, M.P.H., Extramural
Research Program Office, National Center for
Injury Prevention and Control, CDC, 4770
Buford Highway, NE., Mailstop F–63,
Atlanta, Georgia 30341, Telephone: (770)
488–4334.
The Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.

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