[Federal Register Volume 72, Number 121 (Monday, June 25, 2007)]
[Notices]
[Pages 34691-34692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12241]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-07-06BM]


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 Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Randomized Controlled Trial of Routine Screening for Intimate 
Partner Violence--New--National Center for Injury Prevention and 
Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Intimate partner violence (IPV) is a prevalent problem with serious 
health consequences that include death, physical injury, increased 
rates of physical illness, post-traumatic stress, increased 
psychological distress, depression, substance abuse, and suicide. Some 
studies suggest that abuse perpetrated by intimate partners tends to be 
repetitive and escalates in severity over time. This research has been 
the basis for promoting early diagnosis and intervention.
    Health care providers appear to be well situated to identify IPV. 
Women come into contact with health care services routinely for a 
number of reasons such as prenatal care, family planning, cancer 
screening, and well baby care. Women experiencing IPV make more visits 
to emergency departments, primary care facilities, and mental health 
agencies than non-abused women. Considering the magnitude and severity 
of IPV, and the potential role health care providers could play in 
reducing its serious consequences, numerous professional and health 
care organizations have recommended routine screening of women for IPV 
in primary care settings. However, various systematic reviews of the 
literature have not found evidence for the effectiveness

[[Page 34692]]

of screening to improve outcomes for women exposed to IPV.
    Based on the recommendations of a recent expert panel, in order to 
provide this evidence we are proposing to conduct a randomized 
controlled trial. The trial will recruit 3680 women in a public 
obstetrics, gynecology, and family planning clinic. Women attending 
this clinic tend to be African American and of lower socioeconomic 
status. For this study (the Main Study), women will be randomly 
allocated to one of three arms: (1) Screened for IPV, and if disclosing 
IPV, provided information on available IPV services; (2) not screened 
and all receiving information on available IPV services; or (3) a 
control group that will not be screened nor receive information on 
available IPV services. All three arms will be assessed with a self-
report measure for mental health, disability, and quality of life at 
baseline utilizing an audio-computer-assisted structured interview (A-
CASI) and at a 12-month follow-up utilizing a computerized-assisted 
telephone interview (CATI). A pretest with 196 women in this same 
clinic will be conducted to test the enrollment, randomization, 
interview, and follow-up procedures; provide estimates for outcome 
measures and a potential mediator of outcomes (contact of IPV 
services); and establish the concordance between measures used at 
baseline (in the clinic) and at a one-week follow-up over the phone. 
The study arms of the Pretest, which vary slightly from those of the 
Main Study, are designed to accomplish these intermediate objectives. 
The results will be used to refine the measures, procedures, and sample 
size requirements for the Main Study. The results from the Main Study, 
the Randomized Controlled Trial, will guide CDC as well as other 
governmental agencies, professional and health care organizations, and 
women's advocate groups in formulating its recommendations and policies 
regarding routine screening.
    There are no costs to respondents other than their time to 
participate in the survey. The total estimated annualized burden hours 
are 717.7.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
                           Respondents                               Number of     responses per   per response
                                                                    respondents     respondents     (in hours)
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Potential Eligibility for Pretest...............................             210               1            1/60
Pretest Baseline Participants...................................             196               1           15/60
Pretest Follow-up Participants..................................             176               1           12/60
Potential Eligibility for Main Study............................            4600               1            1/60
Main Study Baseline Participants................................            3680               1           17/60
Main Study Follow-up Participants...............................            2580               1           22/60
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    Dated: June 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E7-12241 Filed 6-22-07; 8:45 am]
BILLING CODE 4163-18-P