Attachment B -- 60 Day FRN -- Healthcare Systems for Tracking Colorectal Cancer Screening Tests

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Revised Document
1. The Categories of Individuals
Covered by the System section in the
System of Records Notice (SORN) is
revised to include other HHS personnel
who may treat individuals. The section
is revised as follows:
The individuals covered by the system
are all persons and owners of animals
treated by NDMS and other HHS
medical personnel when the NDMS
Disaster Medical Assistance Teams
(DMATs), National Veterinary Response
Teams (NVRTs), or other HHS medical
personnel are activated to respond to
emergency situations, or as a response
to any other situation for which they are
activated.
2. The Purpose(s) section in the SORN
is revised to include other HHS
personnel who may treat individuals.
The first sentence of that section is
revised to read:
Medical and demographic information
is collected on all patients seen and/or
treated by NDMS or other HHS
personnel.
3. Routine Use No. 1 in the SORN is
revised to clarify that it refers to sharing
information between NDMS partner
agencies, and to include a discussion, at
the end of the routine use, of the
relationship between all of the NDMS
partners regarding the use of medical
records as follows:
NDMS is a coordinated effort between
HHS, the Department of Homeland
Security (DHS), the Department of
Defense (DoD), and the Department of
Veterans Affairs (VA). As such, the
medical treatment and movement of
patients is a shared responsibility
between these partnership agencies. The
medical and demographic information
collected during the treatment of a
patient is shared with the partners to
ensure that patients treated through
NDMS receive the appropriate level of
health care. The health information
disclosed among the partners is limited
to what is needed for continuity of
health care operations.
4. Routine Use No. 4 in the SORN is
revised to include volunteers as follows:
Disclosure to agency contractors,
consultants, grantees, or volunteers who
have been engaged by the agency to
assist in the performance of a service
related to this collection and who have
a need to have access to the records in
order to perform the activity.
5. Routine Use No. 6 in the SORN is
revised to include a discussion, at the
end of the routine use, of the
circumstances when the agency will not
disclose the patient’s location or status
to family members as follows:
Disclosure of a patient’s location or
status is not permitted when there is a

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reasonable belief that disclosing such
information could endanger the life,
safety, health, or well-being of the
patient.
6. In the SORN, in the Policies and
Practices for Storing, Retrieving,
Accessing, Retaining, and Disposing of
Records in the System, in the
Disposition authority subsection, the
first two sentences are revised as
follows:
Patient Care Forms or other Medical
Records created by the Federal Medical
Station(s) (FMS) or by any component of
HHS/ASPR inclusive of NDMS during a
response to an event while caring for
victims of that event are cutoff at the
end of the response activity by the
Federal Medical Station(s) or HHS/
ASPR component for a particular event.
Cutoff refers to breaking, or ending files
at regular intervals, usually at the close
of a fiscal or calendar year, to permit
their disposal or transfer in complete
blocks and, in this case, cutoff is at the
end of the response activity. The cutoff
date marks the beginning of the records
retention period.
Dated: March 3, 2008.
Kevin Yeskey,
Deputy Assistant Secretary, Director, Office
of Preparedness and Emergency Operations.
[FR Doc. E8–6238 Filed 3–26–08; 8:45 am]
BILLING CODE 4150–37–P

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:

SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (0MB) approve the proposed
information collection project: ‘‘Health
Care Systems for Tracking Colorectal
Cancer Screening Tests.’’ 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.
DATES: Comments on this notice must be
received by May 27, 2008.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at: [email protected].

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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
Health Care Systems for Tracking
Colorectal Cancer Screening Tests
AHRQ proposes to implement and
assess a system redesign intervention to
improve colorectal cancer (CRC)
screening and follow-up among patients
50–79 years-old. Other goals of the
intervention include: (1) Achieving a
high level of satisfaction with the
intervention among patients, providers,
and practice staff, (2) promoting patientcentered care through the intervention,
(3) being a cost-effective intervention,
and (4) demonstrating the benefits to
businesses for implementing the
intervention. The research is sponsored
by AHRQ under its ACTION
(Accelerating Change and
Transformation in Organizations and
Networks) program, and will be
conducted for AHRQ by The CNA
Corporation (CNA) and its partners
Thomas Jefferson University (TJU) and
Lehigh Valley Physician Hospital
Organization (LVPHO).
Colorectal cancer screening is
recommended as routine preventive
care and this intervention, which is
consistent with current CRC screening
guidelines, carries no greater risk than
that which occurs in usual delivery of
healthcare (i.e., screening and follow up
done without benefit of this
intervention).
Nevertheless, as part of standard
research practice, the intervention and
assessment protocol will be submitted
to the Institutional Review Boards (IRB)
at both LVPHO and TJU so that they can
review the protocols to ensure that they
are consistent with the requirements of
human subjects protection as outlined
in federal statute, regulations, and
guidelines. These approvals will be
obtained before the study begins.
Additionally, CNA and LVPHO have a
business associate agreement, and all
parties involved with the study (CNA,
LVPHO, and TJU) will comply with the
Health Insurance Portability and
Accountability Act (HIPAA) Privacy
Rule, 45 CFR Parts 160 and 164. To
further protect patient privacy, neither
CNA nor TJU will have access to any
personally-identifiable data. Only PHO
personnel will have access to

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Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices
identifiable data, which they will deidentify before sending to CNA and TJU
for analysis. Consistent with this
protocol, only LVPHO staff will have
access to patient names and addresses
and will conduct all mailings of letters
and related material to patients.
The intervention will be implemented
in both Family Medicine and General
Internal Medicine practices affiliated
with the LVPHO, and will involve 20
intervention practices and 5 control
practices (25 practices total). The
intervention will consist of inviting and
assisting eligible patients of intervention
practices to be screened for CRC,
providing academic detailing to
intervention practice providers
regarding CRC screening and
appropriate follow-up for positive
screens, and assisting providers to
identify and follow up with their
patients who have positive screens.
Patient eligibility criteria for the
intervention include: being between the
ages of 50–79, having no recent CRC
screening test, not having a previous
diagnosis of CRC, and not having a
family history of CRC before age 60.
Eligible patients will be identified
through a two step process: (1) An
electronic records review to identify
potentially eligible patients; and (2) a
mailed Screening Eligibility Assessment
(SEA) form from their primary care
practice to allow potentially eligible
patients to confirm or refute their
eligibility, and provide selected
additional demographic and perceived
health status information. Patients will
also have the opportunity to opt out of
the study on the SEA form.
Patients who are deemed eligible and
have not opted out of the study through
the SEA form will then receive a
mailing from their practice inviting
them to be screened for colorectal
cancer. The invitation will include a
letter on practice letterhead signed by
the practice’s primary care providers, a
brochure that describes the benefits of
CRC screening and the alternative
screening modalities that are consistent
with American Cancer Society
guidelines, a Stool Blood Test (SBT) kit
with an envelope to return it for
processing for those patients who want
to use that screening modality, and a list
of colonoscopists that the practice refers
patients to for those patients who prefer
colonoscopy to a SBT. In addition to the
list of colonoscopists, the accompanying
letter from the practice will also include
wording to make sure patients are aware
they can select other colonoscopists
who may not be on the list. As this
invitation mailing is part of normal
recommended clinical practice and
requires no response on the part of the

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patient other than participating in the
clinically recommended screening, it is
not considered to be a data collection.
Patient electronic records will be
tracked by LVPHO personnel for
evidence of screening. Patients whose
records do not indicate they have been
screened within a certain amount of
time will be sent a reminder letter. As
with the invitation mailing, this
reminder mailing is part of normal
recommended clinical practice and
requires no response on the part of the
patient other than participating in the
clinically recommended screening, and
is not considered to be a data collection.
There will be no additional cost to
patients for CRC screening beyond that
which occurs in the usual delivery of
health care. Patients insured through a
LVPHO insurance product will be
covered for diagnosis and treatment.
Patients covered through non-LVPHO
plans (public as well as private) will
also likely be covered, and such
coverage will be documented to
determine its impact on the
effectiveness of the intervention.
Patients who are underinsured or
uninsured are eligible to use systems for
charity and discounted care available in
the Lehigh Valley Hospital and
Healthcare Network, including access to
hospital clinics and access to financial
advisors.
Clinicians and staff of intervention
practices will participate in a brief
academic detailing session to review the
current evidence-based guidelines for
CRC screening from the American
Cancer Society, to receive information
regarding appropriate follow-up to
positive screens, and to receive the
operational details of the
implementation that will affect the
practice (including being provided
information about the intervention that
may be necessary for answering
questions from patients). Academic
detailing will not be provided to control
practices. As educational information is
only being provided, this component of
the intervention is not a data collection.
Method of Collection
Data will be collected through six
modes: (1) A SEA form; (2) focus groups
of providers and staff at each
intervention and control practice; (3)
brief informal interviews with selected
providers and staff at each practice; (4)
a survey of all clinicians and staff at
each practice; (5) patient chart audits;
and (6) patient focus groups. The data
will be collected to obtain the following
types of information needed for
determining patient eligibility for the
intervention and for conducting an
assessment of the intervention: patient’s

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screening history and eligibility
information; patient demographics;
patient, provider, and practice
satisfaction with the intervention;
practice attitudes; practice procedures
and systems for screening and tracking
results; and patient-perceived barriers
and facilitators for following screening
and follow-up recommendations.
SEA Form
Potentially eligible patients identified
by electronic records review will receive
a SEA form and accompanying letter.
This form will ask patients to confirm
or refute their eligibility based on all
eligibility criteria. The form will also
ask patients for additional sociodemographic and perceived health
status data, and allow patients to opt out
of participation in the intervention if
they so choose.
Practice Focus Groups
The practice focus groups will be
conducted both prior to the intervention
and following the intervention at each
intervention practice. The preintervention focus groups are designed
to collect information to establish a
baseline. The post-intervention focus
groups will be conducted to assess
satisfaction with the intervention and to
identify changes in attitudes and
behaviors regarding screening and
follow-up and changes in management
of normal and abnormal screening tests
resulting from the intervention. In
addition, focus groups at control
practices will be conducted late in the
intervention period to gather
comparison information similar to the
baseline information gathered from
intervention practices.
Brief Informal Interviews
Brief informal interviews with
selected intervention practice providers
and staff will be conducted as a followup to the focus groups to ascertain
additional baseline information about
procedures and systems for screening
results (pre-intervention), and
additional information about each
practice’s experience with the
intervention and facilitators and barriers
to the intervention’s implementation
(post-intervention). In addition, similar
baseline information will be collected
from control practices late in the
intervention period.
Practice Survey
A pre-intervention practice survey of
providers and staff will be administered
in the intervention practices to provide
a baseline of the current CRC screening
environment at each practice. The
survey will be administered again post-

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intervention to ascertain changes in
behavior or attitudes resulting from the
intervention. In addition, the survey
will also be administered in the control
practices late in the intervention period
to gather comparison information
similar to the baseline information
gathered from intervention practices.
Patient Chart Audits
Study personnel will track patient
screening rates and outcomes as well as
follow-up rates at intervention and
control practices by conducting chart
audits on patients whose electronic data
are inconclusive, or on patients who are
part of practices without electronic
medical records (EMR) systems. Chart
audits will be performed by study
personnel; however, practice staff will
be required to identify, locate, and make
charts available to study personnel.
Patient Focus Groups
Focus groups of patients will be
conducted to better understand the
intervention from the patient’s
perspective. Focus groups with the
intervention practices will be held at
two sites geographically situated across
the region. At each site, three focus
groups will be conducted for each of the
following types of intervention patients:
(1) Those who did not get the
recommended screening after receiving
the invitation packet, (2) those who did

get the recommended screening and
whose test was negative, and (3) those
who did get screened and whose test
was positive. For purposes of
comparison, two focus groups of
patients from control group practices
will also be conducted. Participants will
be asked about their attitudes and
beliefs regarding colorectal cancer
screening and what they believe would
help them get the screening they need.
Estimated Annual Respondent Burden
Exhibit I shows the estimated
annualized burden hours for the
respondents to participate in this
project. The SEA form will be sent to a
maximum of 7,500 patients across the
20 intervention practices and will
require an average of 10 minutes to
complete each. Practice focus groups
will be conducted with 10 individuals
per practice, and will last approximately
30 minutes each. The pre-intervention
and post-intervention practice focus
groups will be held with intervention
practices only (20 practices). Focus
groups will also be held at each of the
control practices for comparison
purposes (5 practices). Informal
interviews will be conducted with three
individuals per practice, and will last
about 10 minutes each. The pre and
post-intervention informal interviews
will be conducted among the
intervention practices (20 practices).

Informal interviews will also be
conducted in the control practices for
comparison purposes (5 practices). A
survey of providers and staff will be
conducted with 10 individuals at each
practice, and the survey will take
approximately 15 minutes to complete.
The survey will be administered to the
intervention practices during the pre
and post-intervention practice focus
group (20 practices). The survey will
also be administered to the control
practices for comparison purposes (5
practices). Patient chart audits will be
performed post-intervention at both
intervention and control practices as a
supplement to the information available
through electronic records. Among the
25 practices, about 50 patients from
each practice will have their charts
audited, which should take about 10
minutes per chart. Patient focus groups
will be held post-intervention and will
include six groups of 10 patients from
the intervention group practice sites,
and two groups of 10 patients from the
control group practice sites (80 patients
total). These focus groups are expected
to last about 2 hours. The total burden
for all phases of the project is estimated
to be 1,978.33 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents’ time to participate in the
project. The total cost is estimated to be
$29,844.73.

EXHIBIT 1.—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Data collection mode

Number of
responses per
respondent

Est. time per
respondent
in hours

Total burden
hours

Screening Eligibility Assessment (SEA) Form .................................................
Pre-interventlon practice focus groups ............................................................
Post-intervention practice focus groups ..........................................................
Control practice focus groups ..........................................................................
Pre-intervention informal interviews with selected providers and staff ...........
Post-intervention informal interviews with selected providers and staff ..........
Control informal interviews with selected providers and staff .........................
Pre-intervention survey of clinicians and staff .................................................
Post-intervention survey of clinicians and staff ...............................................
Control survey of clinicians and staff ...............................................................
Chart audits .....................................................................................................
Patient Focus Groups (post-intervention) ........................................................

7,500
20
20
5
20
20
5
20
20
5
25
80

1
10
10
10
3
3
3
10
10
10
50
1

10/60
30/60
30/60
30/60
10/60
10/60
10/60
15/60
15/60
15/60
10/60
2

1250
100
100
25
10
10
2.5
50
50
12.5
208.33
160

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

7,740

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

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

1,978.33

EXHIBIT 2.—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

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Data collection mode
Screening Eligibility Assessment (SEA) Form(1) ............................................
Pre-intervention practice focus groups(2) ........................................................
Post-intervention practice focus groups(2) ......................................................
Control practice focus groups(2) .....................................................................
Pre-intervention informal interviews with selected providers and staff(2) .......
Post-intervention informal interviews with selected providers and staff(2) .....
Control informal interviews with selected providers and staff(2) .....................
Pre-intervention survey of clinicians and staff(2) ............................................

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Total burden
hours

7,500
20
20
5
20
20
5
20

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Average hourly wage rate*

1,250
100
100
25
10
10
2.5
50

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$12.54
28
28
28
28
28
28
28

Total cost
burden
$15,675
2,800
2,800
700
280
280
70
1,400

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EXHIBIT 2.—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents

Data collection mode

Total burden
hours

Average hourly wage rate*

Total cost
burden

Post-intervention survey of clinicians and staff(2) ...........................................
Control survey of clinicians and staff(2) ..........................................................
Chart audits(3) .................................................................................................
Patient Focus Groups (post-intervention)(1) ...................................................

20
5
25
80

50
12.5
208.33
160

28
28
10
12.54

1,400
350
2,083.33
2,006.40

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

7,740

1,978.33

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

29,844.73

(1) Patient average hourly wage based
on the average per capita income of
$26,088 (computed into an hourly wage
rate of $12.54) in Lehigh Valley,
Pennsylvania: ‘‘Demographic
Information for the Lehigh Valley’’ from
the Lehigh Valley Economic
Development Corporation 2006.
(2) Provider and practice hourly wage
based on an average of the following
estimates from LVPHO: physician =

$70/hour; manager = $19/hour; clinical
staff = $13/hour; and clerical staff =
$10/hour.
(3) Practice clerical staff will retrieve
the charts to be audited by study
personnel; therefore only the time of the
practice staff is included in Exhibit 1
and in the Exhibit 2 cost estimate.
Practice clerical staff hourly wage is
estimated by LVPHO to be $10/hour.

Estimated Annual Costs to the Federal
Government
The estimated total cost to the Federal
government is $271,764.68. The average
annualized cost over the two years of
the project is $135,882.34 per year.
Exhibit 3 shows a breakdown of the
costs.

EXHIBIT 3.—ESTIMATED ANNUAL COSTS TO THE FEDERAL GOVERNMENT
Component

Year 2

Total

The cost of developing the data collection instruments ..............................................................
The cost of implementing the data collections ............................................................................
The cost of analyzing the data and publishing the results .........................................................

$24,765.38
99,061.52
49,530.76

$0
24,601.75
73,805.26

$24,765.38
123,663.27
123,336.02

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

173,357.66

98,407.02

271,764.68

Request for Comments

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Year 1

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 and health
care 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.

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Dated: March 20, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–6073 Filed 3–26–08; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0180]

Draft Guidance for Industry on
Coronary Drug Eluting Stents–
Nonclinical and Clinical Studies;
Availability
AGENCY:

Food and Drug Administration,

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Coronary Drug
Eluting Stents—Nonclinical and
Clinical Studies.’’ This draft guidance is
intended to provide recommendations
to sponsors or applicants planning to
develop, or to submit to FDA, a
marketing application for a coronary
drug eluting stent (DES). The draft
guidance discusses the clinical studies

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Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 25, 2008.

DATES:

Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to

ADDRESSES:

HHS.
ACTION:

that should be performed and the data
that should be submitted to support
such an application. The draft guidance
is being issued in two parts. The
companion document provides
additional and more detailed guidance
on some of the recommendations
included in this document. The
companion document is intended to be
used together with this draft guidance.

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