Attachment L -- Federal Register Notice

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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Notices

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQs 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 15, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–1953 Filed 1–29–10; 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

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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:
‘‘Evaluation of the GuideLines Into
Decision Support (GLIDES).’’ In
accordance with the Paperwork
Reduction Act of 1995, 44 U.S.C.
3506(c)(2)(A), AHRQ invites the public
to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on November 27th, 2009 and
allowed 60 days for public comment. No
comments were received. The purpose

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of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by March 3, 2010.
ADDRESSES: Written comments should
be submitted to: AHRQs OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s 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].
SUPPLEMENTARY INFORMATION:

Proposed Project
Evaluation of the GuideLines Into
Decision Support (GLIDES)
With this project AHRQ proposes to
evaluate how the translation of clinical
knowledge into clinical decision
support can be routinized in practice
and taken to scale in ways that improve
the quality of healthcare delivery for
children in the U.S. Previously in the
GLIDES project, AHRQ designed and
implemented decision support tools
based on guidelines for the prevention
of pediatric overweight and obesity and
the management of chronic asthma in
the pediatric population (publication
forthcoming). In this phase of the
project, conducted for AHRQ through a
contract with Yale University and
Nemours, physicians will be surveyed
about their experiences with the
decision support tools developed in the
previous phase. The participating study
institutions (Yale University and
Nemours) are geographically and
organizationally diverse, and include a
wide range of patients from a variety of
social, economic and ethnic
backgrounds. This project directly
addresses AHRQ’s mission of improving
health systems practices, in particular
for priority populations, including lowincome groups, minority groups,
women, children, and individuals with
chronic diseases. See 42 USC
299(c)(1)(B).
The evaluation plan includes a
physician survey component and an
extraction of electronic medical record
data. Participating physicians will be
surveyed about their experiences with
the decision support tools developed for
this project. This will allow AHRQ to
evaluate the fulfillment of knowledge
transformation goals and the

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effectiveness of the decision support
tools in improving the quality of health
care at the chosen sites. Without such
an evaluation, it would be difficult to
determine whether this project has met
AHRQ’s goals of enhancing the ‘‘quality,
appropriateness and effectiveness of
health services.’’ See 42 USC 299(b); 42
USC 299a(a)(1). Consequently, it is
necessary to collect this information to
fulfill AHRQ’s mission.
Method of Collection
Self-administered questionnaires will
be used to elicit physicians’ general
opinions of guideline-based care and
clinical decision support tools on a five
point Likert-type scale. Results from
low-utilizing physicians will be
compared to high-utilizing physicians to
determine whether general opinions of
guidelines and technology correlate
with actual practice. Results will also be
analyzed by demographic characteristics
included in the survey questionnaire to
determine whether opinions vary by
age, degree of computer experience and
skill, level of training and professional
degree. These analyses will be
important to future studies and decision
support designers because they will
help us understand whether
interventions need to be targeted
differently to different audiences. For
example, senior level specialists may
have less desire or need for clinical
decision support tools than novice
generalists have. In-person qualitative
interviews lasting approximately 30
minutes will be conducted with key
personnel at each site (including
physicians, nurse practitioners, and
respiratory therapists). Participants will
remain anonymous in the transcribed
interviews. The interviews will be
analyzed using standard qualitative
techniques to explore barriers and
facilitators to using the clinical decision
support tool. The Human Investigation
Committee (HIC) at Yale University has
reviewed this protocol. The HIC found
the survey study to be exempt from
review under 45 CFR 46.101(b)(2). The
HIC approved the interview study and
required signed informed consent from
participants.
Electronic medical record data will be
extracted into an electronic spreadsheet
for analysis. This extraction will occur
at regular intervals to ensure continued
maintenance and uptake of the tool.
Utilization of the decision support tools
at the provider and site level will be
assessed based on the rate of electronic
chart documentation. This is important
to determine the rate of uptake of the
intervention, as well as to determine
whether there are any flaws in the
design of the tool. Congruence of actual

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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Notices
practice with guideline
recommendations will be assessed
based on automatically generated
disagreement flags in the electronic
medical record as well as by manual
chart review. This data collection,
including the manual chart review, will
be performed by project staff and will
not impose a burden on the
participating sites. In addition, project
staff will directly observe a random
sampling of clinicians using the tool in
clinical settings to determine how the
tool affects workflow. These
observations will not require any effort,
time or action on the part of the
clinicians themselves and will not
impose a burden on the participating
sites.

Signed informed consent will be
obtained prior to any observations. The
Human Investigation Committee at Yale
University has reviewed this protocol. It
approved the medical record review,
approved direct observation of
clinicians and interviews of clinicians,
required signed informed consent from
clinicians, granted a waiver of informed
consent from patients per 45 CFR
46.116(d), and granted a waiver of
HIPAA authorization.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. The Asthma Management and
Clinical Decision Support System
Usability and User Satisfaction Survey
(asthma questionnaire) will be

completed by 172 health care
professionals across 3 sites and is
expected to require about 6 minutes to
complete. The Obesity Prevention and
Clinical Decision Support System
Usability and User Satisfaction Survey
(obesity questionnaire) will be
completed by 82 health care
professionals across 2 sites and is
expected to require about 6 minutes to
complete. The in-person interviews will
be conducted with a total of 50
clinicians at 3 sites and are expected to
last 30 minutes each. The total burden
is estimated to be 51 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated to be $2,781.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Number of sites

Number of
responses per
site

Hours per
response

Total burden
hours

Asthma questionnaire—Yale ...........................................................
Asthma questionnaire—Nemours ....................................................
Obesity questionnaire—Yale ...........................................................
Obesity questionnaire—Nemours ....................................................
In-person interviews—Yale ..............................................................
In-person interviews—Nemours ......................................................

2
1
1
1
2
1

31
110
57
25
15
20

6/60
6/60
6/60
6/60
30/60
30/60

6
11
6
3
15
10

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

8

............................

............................

51

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Form name

Number of sites

Total burden
hours

Average hourly
wage rate*

Total cost burden

Asthma questionnaire—Yale ...........................................................
Asthma questionnaire—Nemours ....................................................
Obesity questionnaire—Yale ...........................................................
Obesity questionnaire—Nemours ....................................................
In-person Interviews—Yale ..............................................................
In-person Interviews—Nemours ......................................................

2
1
1
1
2
1

6
11
6
3
15
10

$59.83
59.83
47.25
47.25
53.54
53.54

$359
658
284
142
803
535

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

8

51

............................

2,781

*Based upon the mean of the average wages for other physicians and surgeons, general pediatricians, and pediatric trainees (asthma questionnaire), and general pediatricians and pediatric trainees (obesity questionnaire), National Compensation Survey: Occupational wages in the
United States 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics,’’ and Yale Pediatric Residency Program, 2008.

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost for this research. Since

this project will not exceed one year the
total and annualized costs are identical.
The total cost is estimated to be $5,703.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

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Cost component

Total cost

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

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$1,406
416
780
1,601
200
1,299

Annualized cost
$1,406
416
780
1,601
200
1,299

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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component

Total cost

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

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 health care research, quality
improvement and 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 25, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–1894 Filed 1–29–10; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–0745]

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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 and
send comments to Maryam Daneshvar,

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CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
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
Colorectal Cancer Screening Program
(OMB Number 0920–0745, exp. 7/31/
2010)—Revision—Division of Cancer
Prevention and Control (DCPC),
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Colorectal Cancer (CRC) is the second
leading cause of cancer-related deaths in
the United States, following lung
cancer. Based on scientific evidence
which indicates that regular screening is
effective in reducing CRC incidence and
mortality, regular CRC screening is now
recommended for average-risk persons.
Screening tests that are recommended
by the United States Preventive Services
Task Force, and that may be used alone
or in combination, include fecal occult
blood testing (FOBT), fecal
immunochemical testing (FIT), flexible
sigmoidoscopy, colonoscopy, and/or
double-contrast barium enema (DCBE).
In 2005, CDC established a three-year
demonstration program, subsequently
extended to four years, to screen lowincome individuals 50 years of age and
older who have no health insurance or
inadequate health insurance for CRC.
The five demonstration sites report
information to CDC including deidentified, patient-level demographic,
screening, diagnostic, treatment,
outcome and cost reimbursement data
(OMB No. 0920–0745, exp. 7/31/2010).

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5,703

Annualized cost
5,703

The information is being used to assess
the feasibility and cost effectiveness of
a publicly funded screening program
and describe key outcomes, and has
been critical in guiding the expansion of
the program.
CDC will request OMB approval to
continue the information collection for
three years, with changes. First, the
number of funded sites will increase
from 5 to 26, and the term
‘‘Demonstration’’ will be deleted from
the title of the program. Second, there
will be a reduction in the burden per
respondent associated with the
collection of clinical information.
Reporting forms for medical
complications and medically ineligible
clients will be discontinued, and
reporting forms for colorectal cancer
clinical data elements (CCDE) will be
streamlined. Data elements that were
underused in analysis of the
demonstration program data, or difficult
to standardize across programs, will be
removed, and the level of detail
collected from endoscopy and pathology
reports will be reduced. As a result, the
reporting burden per CCDE form will be
similar regardless of primary test
provided. Third, the collection of
patient-level reimbursement cost data
will be discontinued and will be
replaced by the collection of programlevel activity-based cost data. The
revised information collection will
utilize a Cost Assessment Tool (CAT)
currently in use by another CDC-funded
cancer program (OMB No. 0920–0812,
exp. 6/30/2012). The information to be
collected through the CAT will allow
CDC to compare activity-based costs
across multiple sites and programs, and
will provide a more effective means of
monitoring and improving the
performance and cost-effectiveness of
the CRC screening program.
The goals of the expanded CRC
screening program are to increase
population-based screening and to
reduce health disparities in CRC
screening, incidence and mortality. The
program will continue to provide
services to low-income individuals age
50 and older with inadequate or no
health insurance. Each site will screen
an estimated 375 patients per year (186
semiannually). The increase in the
number of funded sites and the
proposed changes will result in an

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