[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.

------------------------------------------------------------------------
                                                               Average  
                                  Number of     Number of      burden/  
          Respondents            respondents   responses/     response  
                                               respondent     (in hrs.) 
------------------------------------------------------------------------
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.)   
----------------------------------------------------------------------------------------------------------------
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.)   
----------------------------------------------------------------------------------------------------------------
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