[Federal Register Volume 62, Number 53 (Wednesday, March 19, 1997)]
[Notices]
[Pages 13157-13158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6887]
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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.
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Average
Number of Number of burden/
Respondents respondents responses/ response
respondent (in hrs.)
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HMO Enrollees................. 6165 1 .3473
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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.
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Average
Number of Number of burden/ Total
Respondents respondents responses/ response burden (in
respondent (in hrs.) hrs.)
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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.
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Average
Number of Number of burden/ Total
Respondents respondents responses/ response burden (in
respondent (in hrs.) hrs.)
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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
