Proposed Data Collections Submitted for Public Comment and Recommendations, 57878-57879 [05-19827]
Download as PDF
<![CDATA[
57878
Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Notices
safety and quality of care and other
patient protections. The emphasis is on
major regulations issued within the last
ten (10) years.
ASPE requests that commenters, in
the selection of which reform ideas to
submit, consider the extent to which (1)
Benefits (quantitative and/or qualitative)
are likely to exceed costs for the reform,
(2) benefits (quantitative and/or
qualitative) can be increased without
exceeding costs, (3) the suggested
change would improve patients’ health
and quality of care, (4) the agency or
multiple agencies have statutory
authority to make the suggested change,
and (5) the rule or program is a major
contributor to the regulatory burden
imposed on the health care sector.
While both legislative and
administrative reforms are welcome,
administrative reforms such as those
that require discretionary rulemaking
are more likely to be initiated in a
timely manner. The reforms may
include modifying, extending, or
rescinding regulatory programs,
guidance documents or paperwork
requirements.
Once we receive the nominations
from the public, HHS, in cooperation
with OMB, will assemble and evaluate
the reform nominations and discuss
each of them with the relevant HHS
Operating Divisions, taking into account
statutory, economic, public health, and
budgetary considerations.
ASPE requests that
nominations (including explanations of
the suggested reforms) be submitted in
writing electronically to ASPE at
ReducingRegulatoryBurden@hhs.gov
within 30 calendar days from the date
of publication of this notice in the
Federal Register.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Marty McGeein, Office of the Assistant
Secretary for Planning and Evaluation,
200 Independence Avenue, SW.,
Washington, DC 20201. Telephone:
(202) 690–6443.
Dated: September 20, 2005.
Michael J. O’Grady,
Assistant Secretary for Planning and
Evaluation (ASPE), HHS.
John D. Graham,
Administrator, Office of Information and
Regulatory Affairs (OIRA), OMB.
[FR Doc. 05–19788 Filed 10–3–05; 8:45 am]
BILLING CODE 4150–05–P
VerDate Aug<31>2005
16:55 Oct 03, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–05–05CZ]
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 404–371–5983 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
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
Assessing Diabetes Detection
Initiative for Policy Decisions—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Type 2 diabetes is a chronic disease
that affects more than 18 million
Americans, approximately 5 million of
whom do not know that they have the
disease. As the disease progresses, it
often causes severe complications,
including heart disease, blindness,
lower extremity arterial disease, and
kidney failure. Native Americans,
African Americans, Latino Americans,
and some Asian Americans and Pacific
Islanders are disproportionately affected
by diabetes. Identifying persons who
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
have undiagnosed diabetes and treating
them could prevent or delay diabetes
complications.
In November 2003 the Diabetes
Detection Initiative (DDI) was launched
in 10 pilot sites around the U.S. to
identify a portion of the estimated 5
million people with undiagnosed Type
2 diabetes, targeting specific areas in
each of 10 locales in which residents are
likely to be at higher risk for Type 2
diabetes. Implementation of the DDI
involved distributing a paper-and-pencil
risk test. Individuals whose score
indicated that they were at an increased
risk for diabetes were advised to see
their regular doctor (or to schedule an
appointment at one of several clinics
that had agreed to participate in the
DDI) to receive a finger-stick or other
tests to confirm whether or not they
have diabetes. Whether or not the DDI
should be expanded to other
communities depends on the health
benefits and costs of the program. The
CDC is planning to conduct a study to
provide this critical information.
The planned study will assess the
resources used, the cost per case
detected, and the perceived benefit of
the DDI to participants. Data for the
economic assessment will be obtained
by conducting surveys of local DDI
implementation teams, leadership at
participating health clinics, and patients
at participating health clinics. The
results of the study will also provide
information needed for conducting a
more complete cost-effectiveness
analysis of screening for undiagnosed
diabetes.
The point-of-contact (Implementation
team member) in each of the 10 regions
will be sent a mail survey to collect
information regarding the staff time and
other resources used to implement the
DDI program (including the staff time
and resources used by community-based
organizations that participated in the
DDI implementation). These planning
and implementation activities include
participating in meetings and
conference calls, recruiting clinics and
community-based organizations to
participate in the DDI, distributing risk
tests, organizing health fairs and other
community events, and designing media
campaigns to promote the DDI.
The health clinic leadership survey
will be mailed to one person at each of
the 43 clinics that participated in the
DDI implementation. The survey will
collect information regarding the costs
associated with the clinic’s participation
in the DDI. These will include the
medical costs of providing care to
patients who visited the clinic as a
result of the DDI, staff time associated
with DDI planning and implementation,
E:\FR\FM\04OCN1.SGM
04OCN1
57879
Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Notices
and any staff time that was devoted to
performing finger stick tests at locations
other than the health clinic (e.g., health
fairs, shopping malls, work sites,
housing complexes). Of the 43 clinics to
be surveyed, we expect that 30 (70%)
will complete the survey.
A computer-assisted in-person
interview will be administered to 600
clinic patients—60 in each of the 10
regions in which the pilot DDI was
implemented. The survey will collect
background information, out-of-pocket
medical and non-medical direct health
care costs (e.g., co-payments,
transportation costs, value of patients’
time associated with the clinic visit),
and preferred features of a diabetes
screening program. There are no costs to
respondents other than their time.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Average burden per
response
(in hours)
Number of respondents
Number of responses per
respondent
Implementation team members .......................................................................
Clinic staff ........................................................................................................
Patients at DDI clinics .....................................................................................
10
30
600
1
1
1
2
1
20/60
20
30
200
Total ..........................................................................................................
640
........................
........................
250
Respondents
Dated: September 27, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–19827 Filed 10–3–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–05–0439x]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 371–5983 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Human
Resources and Housing Branch, New
Executive Office Building, Room 10235,
Washington, DC 20503 or by fax to (202)
395–6974. Written comments should be
received within 30 days of this notice.
Proposed Project
Assessment of State Early Hearing
Detection and Intervention Programs
(EHDI): A Program Operations
Evaluation Protocol—New—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description:
Every year, an estimated 12,000
newborns are diagnosed with
VerDate Aug<31>2005
16:55 Oct 03, 2005
Jkt 205001
permanent hearing loss, a condition that
if not identified and treated early can
lead to impaired functioning and
development. CDC’s role in the
detection, diagnosis, and treatment of
early hearing loss through the ‘‘Early
Hearing Detection and Intervention
Program’’ (EHDI) is of vital importance
for families of newborns and infants
affected by hearing loss. Nonetheless,
recent data indicate that only 60 percent
of the newborns that fail hearing
screening are evaluated by the
recommended 3 months of age.
The evaluation will involve an
integrative evaluation approach that
encompasses the following activities,
conducted in Arkansas, Massachusetts,
Michigan, Utah, and Virginia: (1) A 10minute survey of 3,000 mothers whose
newborns have been screened (the
‘‘Maternal Exit Survey’’); and (2) a 20minute computer-assisted telephone
interviewing (CATI) survey of 1,000
mothers of newborns who have been
referred for additional hearing
evaluation (the ‘‘Maternal CATI
Interview.’’) To complete these
interviews, it is expected that 5,000 will
be contacted. The overall burden on all
contacted women is expected to be
approximately 940 hours. The Maternal
Exit Survey and the Maternal CATI
Interview will address the following
research questions: (1) What are the
factors that impede or enable families to
follow-up for early hearing evaluation
and intervention; (2) What EHDI
strategies implemented by hospitals
appear to be most successful in reducing
loss to follow-up; and (3) Is loss to
follow-up associated with maternal
characteristics such as parity, age or
ethnicity? Both surveys will be available
in English and Spanish.
Hearing loss is the most common
disorder that can be detected through
newborn screening programs. Prior to
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Total burden
hours
the implementation of newborn hearing
screening, children with hearing loss
typically were not identified until 2 to
3 years of age. This is well beyond the
period of early language development.
Now, with comprehensive EHDI
programs, the average age of
identification of children with hearing
loss has been reduced so that it is now
possible to provide interventions for
children younger than one year of age.
With early identification, children with
hearing loss can begin receiving
appropriate intervention services that
provide the best opportunity for these
children to reach their maximum
potential in such areas as language,
communication, social and emotional
development, and school achievement.
Newborn hearing screening is only
the first step in the identification of
children with hearing loss. Children
who do not pass their screening need to
be further evaluated to determine if they
have hearing loss. The value of newborn
hearing screening cannot be realized
unless children complete the screening,
evaluation, and intervention process.
Since recent data indicate that nearly 40
percent of children do not complete the
evaluation-intervention process, this
project is designed to understand what
barriers exist in following through with
evaluation and intervention. This
evaluation also plans to provide data
necessary to develop innovative
solutions that can be applied by states,
hospitals, and local programs. Results
from this collection have the potential
to strengthen the EHDI process and
minimize social and economic disability
among persons born with hearing loss.
By evaluating the policy, structural,
personal, and financial factors and
barriers associated with loss to followup in the EHDI program, this study
seeks to identify ‘‘best practices’’ for
improving detection, referral to
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 70, Number 191 (Tuesday, October 4, 2005)]
[Notices]
[Pages 57878-57879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05-05CZ]
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 404-371-5983
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
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
Assessing Diabetes Detection Initiative for Policy Decisions--New--
National Center for Chronic Disease Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Type 2 diabetes is a chronic disease that affects more than 18
million Americans, approximately 5 million of whom do not know that
they have the disease. As the disease progresses, it often causes
severe complications, including heart disease, blindness, lower
extremity arterial disease, and kidney failure. Native Americans,
African Americans, Latino Americans, and some Asian Americans and
Pacific Islanders are disproportionately affected by diabetes.
Identifying persons who have undiagnosed diabetes and treating them
could prevent or delay diabetes complications.
In November 2003 the Diabetes Detection Initiative (DDI) was
launched in 10 pilot sites around the U.S. to identify a portion of the
estimated 5 million people with undiagnosed Type 2 diabetes, targeting
specific areas in each of 10 locales in which residents are likely to
be at higher risk for Type 2 diabetes. Implementation of the DDI
involved distributing a paper-and-pencil risk test. Individuals whose
score indicated that they were at an increased risk for diabetes were
advised to see their regular doctor (or to schedule an appointment at
one of several clinics that had agreed to participate in the DDI) to
receive a finger-stick or other tests to confirm whether or not they
have diabetes. Whether or not the DDI should be expanded to other
communities depends on the health benefits and costs of the program.
The CDC is planning to conduct a study to provide this critical
information.
The planned study will assess the resources used, the cost per case
detected, and the perceived benefit of the DDI to participants. Data
for the economic assessment will be obtained by conducting surveys of
local DDI implementation teams, leadership at participating health
clinics, and patients at participating health clinics. The results of
the study will also provide information needed for conducting a more
complete cost-effectiveness analysis of screening for undiagnosed
diabetes.
The point-of-contact (Implementation team member) in each of the 10
regions will be sent a mail survey to collect information regarding the
staff time and other resources used to implement the DDI program
(including the staff time and resources used by community-based
organizations that participated in the DDI implementation). These
planning and implementation activities include participating in
meetings and conference calls, recruiting clinics and community-based
organizations to participate in the DDI, distributing risk tests,
organizing health fairs and other community events, and designing media
campaigns to promote the DDI.
The health clinic leadership survey will be mailed to one person at
each of the 43 clinics that participated in the DDI implementation. The
survey will collect information regarding the costs associated with the
clinic's participation in the DDI. These will include the medical costs
of providing care to patients who visited the clinic as a result of the
DDI, staff time associated with DDI planning and implementation,
[[Page 57879]]
and any staff time that was devoted to performing finger stick tests at
locations other than the health clinic (e.g., health fairs, shopping
malls, work sites, housing complexes). Of the 43 clinics to be
surveyed, we expect that 30 (70%) will complete the survey.
A computer-assisted in-person interview will be administered to 600
clinic patients--60 in each of the 10 regions in which the pilot DDI
was implemented. The survey will collect background information, out-
of-pocket medical and non-medical direct health care costs (e.g., co-
payments, transportation costs, value of patients' time associated with
the clinic visit), and preferred features of a diabetes screening
program. There are no costs to respondents other than their time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Implementation team members..................... 10 1 2 20
Clinic staff.................................... 30 1 1 30
Patients at DDI clinics......................... 600 1 20/60 200
-----------------
Total....................................... 640 .............. .............. 250
----------------------------------------------------------------------------------------------------------------
Dated: September 27, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-19827 Filed 10-3-05; 8:45 am]
BILLING CODE 4163-18-P
