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. 

ADDRESSES: 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. 

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 

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, 

Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Notices 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

Respondents Number of respondents 

Number of responses per 

respondent 

Average burden per 

response 

(in hours) 

Total burden 

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 

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 

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 10- 

minute survey of 3,000 mothers whose 

newborns have been screened (the 

‘‘Maternal Exit Survey’’); and (2) a 20- 

minute 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 

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