Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 DAY-197]

Agency Forms Undergoing Paperwork Reduction Act Review

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 Office on (404) 639-7090. Send written

comments to CDC, Desk Officer; Human Resources and Housing Branch, New

Executive Office Building, Room 10235; Washington, DC 20503. Written

comments should be received within 30 days of this notice.

The following requests have been submitted for review since the

last publication date on March 12, 1997.

Proposed Project

1. Examination of Barriers to Participant Compliance in a Flexible

Sigmoidoscopy Screening Program. Kaiser Foundation, Oakland--New--With

colorectal cancer comprising the second highest mortality rate among

all U.S. cancers and ranked as the fourth most common form of cancer,

the active promotion of population-based screening and early detection

is becoming increasingly important. Recognizing the importance of

screening, American Cancer Society guidelines and the new US Preventive

Services Task Force guidelines recommend colorectal cancer screening

for individuals over the age of 50. Still, although early detection of

colorectal neoplasms has been effectively demonstrated to significantly

reduce morbidity and mortality and associated economic costs,

compliance is very low. This three-year study involving investigators

at one of the nation's largest Health Maintenance Organizations''

research foundation (Kaiser Foundation of Northern California) seeks to

identify barriers associated with low compliance in a colorectal cancer

screening program utilizing flexible sigmoidoscopy.

Phase I will target and recruit participants from an existing pool

of Health Maintenance Organization enrollees who are at a relatively

high age-related risk (ages 50-64) for developing colorectal cancers

via short survey and invitation to screening. In Phase II,

investigators will conduct a telephone survey to identify the relative

impact of economic, psychological, and related factors on participation

and non-participation in the mass screening programs. In phase III,

investigators will analyze and widely disseminate results of the study

via publication in the professional literature. Results will also be

made available to participants upon request. Interventions designed to

mitigate the barriers identified through this study will be

incorporated into future screening efforts and general health

education/health promotion efforts.

Participation in this study is voluntary and subsequent follow-up

and treatment, if indicated, will be provided at no cost to

participants. Informed consent will be obtained where appropriate and

oversight will be provided by federal and institutional review. The

total annual burden hours are 2,141.

------------------------------------------------------------------------

Average

Number of Number of burden/

Respondents respondents responses/ response

respondent (in hrs.)

------------------------------------------------------------------------

HMO Enrollees................. 6165 1 .3473

------------------------------------------------------------------------

2. Reliability and Validity Assessment of the Use of Scales of

Stressful Life Events in Black Women of Reproductive Age (0920-0356)--

Extension--A CDC review of studies of psychosocial factors and adverse

pregnancy outcome supports the hypothesis that high levels of exposure

to stressful life experiences put black women at increased risk for

adverse reproductive outcome, particularly Preterm Delivery (PTD) and

Very Low Birth Weight (VLBW). The purpose of this study is to evaluate

the reliability and validity of existing instruments that measure

stressful life events in black women of reproductive age. Respondents

will consist of reproductive age residents who live in the Atlanta area

and may attend a health care facility that has a behavioral prenatal

unit. Approximately one half the women will be pregnant at the time of

data collection.

Women enrolled in the study respond to a series of demographic and

psychosocial questionnaires. They also ask that women provide a 24 hour

urine sample and saliva sample. Both samples are used to correlate

reported levels of stress with laboratory measures of stress.

Participation in this study is voluntary and participants will

receive a reimbursement for their time. A written informed consent will

be obtained and local institutional review will provide oversight.

The study is ongoing and by December 31, 1996, approximately two-

thirds of data collected was completed. Approximately 130 women need to

be interviewed. This leaves 130 women in the validity study, of which

30 women will repeat the process for the reliability study. The total

annual burden hours are 1,134.

----------------------------------------------------------------------------------------------------------------

Average

Number of Number of burden/ Total

Respondents respondents responses/ response burden (in

respondent (in hrs.) hrs.)

----------------------------------------------------------------------------------------------------------------

Screening.................................................. 300 1 .083 25

Validity study group--African-American Women for the ages

of 18 to 45............................................... 100 1 7.07 707

Reliability study group--African-American Women for the

ages of 18 to 45.......................................... 30 1 13.4 402

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[[Page 13158]]

3. Survey Component of the CDC's Prevention Marketing Initiative

Local Demonstration Site Project Evaluation --NEW-- The Centers for

Disease Control and Prevention, National Center for HIV, STD, and TB

Prevention, Division of HIV/AIDS Prevention, Behavioral Intervention

Research Branch is planning to conduct a cross-sectional tracking study

as part of the evaluation of a five-city HIV prevention demonstration

program. The program involves the integration of social marketing

strategies and community participation in an effort to develop and

implement HIV prevention activities.

Charged with developing programs for those 25 years of age and

younger, community groups in the local demonstration sites chose to

segment the target audience even further, and to mount a variety of

types of interventions. Decisions about segmentation and the nature of

local interventions were based on formative research conducted in each

community. It is hoped that this demonstration project will result in

reductions in HIV risk behavior among members of the target audiences,

as well as in enhanced collaboration among individuals and

organizations in the participating communities.

As part of the evaluation of the effectiveness of the

interventions, questionnaire data will be collected in three of the

demonstration communities. These data will be collected at four time

points over a two year period after prevention activities and message

campaigns are launched. Baseline survey data have been collected

recently under OMB No.0920-0343 (Evaluation of the National AIDS

information and Education Program Activities). The total annual burden

hours are 4,260.

----------------------------------------------------------------------------------------------------------------

Average

Number of Number of burden/ Total

Respondents respondents responses/ response burden (in

respondent (in hrs.) hrs.)

----------------------------------------------------------------------------------------------------------------

Eligibility Screening...................................... 157,680 1 0.01667 2,628

Consent.................................................... 5,768 1 0.05 289

Young People under 25 years of age in targeted prevention

program communities....................................... 3,504 1 0.3833 1,343

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Dated: March 13, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning And Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 97-6887 Filed 3-18-97; 8:45 am]

BILLING CODE 4163-18-P