Randomized Controlled Trial for Routine Screening for Intimate Partner Violence

Forms and Documents

Document Name	Status
Form no number Eligibility Script for Main Study Form	New
Form no number Pretest Followup Form	Modified
Form no number Follow-up Questionnaire Main Study Form	Modified
Form no number Baseline Questionnaire Main Study Form	Modified
Form no number Baseline Questionnaire Form	Modified
Form no number Eligibility Script for Pretest Form	Modified
ATTACHMENT G-QOL SF-12 Spanish.doc Supplementary Document	2010-04-16
OMB SUPP STMT Part B revision-09.doc Supporting Statement B	2010-02-25
Attachment G.pdf Supplementary Document	2010-03-01
ATTACHMENT H - public comment.docx Supplementary Document	2010-02-25
ATTACHMENT D - IRB Continuation Approval.doc Supplementary Document	2010-02-25
ATTACHMENT C.docx Supplementary Document	2010-02-25
Published 60 day page 2.pdf Supplementary Document	2010-02-25
Published 60 day page 1.pdf Supplementary Document	2010-02-25
ATTACHMENT A.docx Supplementary Document	2010-02-25
OMB SUPP STMT Part A 2_11_10.docx Supporting Statement A	2010-03-10

IC Document Collections

IC ID	Document Title	Status
192297	Eligibility Script for Main Study Form	New
181532	Pretest Followup Form	Modified
181531	Follow-up Questionnaire Main Study Form	Modified
181530	Baseline Questionnaire Main Study Form	Modified
181529	Baseline Questionnaire Form	Modified
181528	Eligibility Script for Pretest Form	Modified

ICR Details

OMB Control No: 0920-0761	ICR Reference No: 201003-0920-008
Status: Historical Active	Previous ICR Reference No: 200812-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Randomized Controlled Trial for Routine Screening for Intimate Partner Violence
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/26/2010
	Date Received in OIRA: 03/17/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2013	36 Months From Approved	01/31/2011
Responses	1,753	0	3,814
Time Burden (Hours)	308	0	718
Cost Burden (Dollars)	0	0	0

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Abstract: Intimate partner violence (IPV) occurs frequently and has serious health, economic, and social consequences. Given the seriousness of this problem, numerous professional and health care organizations have recommended routine screening of women for IPV by health care providers in primary care settings. The Centers for Disease Control and Prevention (CDC) is requesting approval of revisions resulting from findings after conducting the Pretest.

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Authorizing Statute(s): US Code: 42 USC 391 Name of Law: Public Health Service Act Prevention and Control of Injuries
   US Code: 42 USC 301 Name of Law: Public Health Service Act Research and Investigation General
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 66976	12/17/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 8955	02/26/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Follow-up Questionnaire Main Study	no number	Follow-up
Pretest Followup	no number	Follow-up
Eligibility Script for Pretest	no number	Eligibility Script
Baseline Questionnaire	no number	Baseline
Baseline Questionnaire Main Study	no number	Baseline
Eligibility Script for Main Study	no number	Eligibility Script

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,753	3,814	0	-2,061	0	0
Annual Time Burden (Hours)	308	718	0	-410	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The proposed changes are based on findings from the Pretest that showed high number of Spanish speakers at recruitment clinics, a higher prevalence of reported exposure to intimate partner violence, and redundancy of the 20-item mental health scale with other measures being used. This revision results in a reduction of burden hours.

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Annual Cost to Federal Government: $475,556

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 03/17/2010

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