HIV/AIDS Risk Reduction Interventions for African-American Heterosexual Men

Forms and Documents

Document	Type	Status	Availability
0920-10CM_Att5c6_Reminder Letter UNCG 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Repair queued
0920-10CM_Att5c4_Invitation to Email Screening UNCG 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att5c3_Recruitment Script UNCG 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att5c1_Invitation Intervention UNCG 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att4c_Consent Forms UNCG 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att4b_Consent Forms 8NYBC 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Repair queued
0920-10CM_Att4a_Consent Forms SUNY 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att3i_BL and FU Assessments UNCG 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att3h_BL and Assessments NYBC 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Repair queued
0920-10CM_Att3g_BL and Assessments SUNY 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_Att3b_Screening Form NYBC 11[1].15.2010-clean.docx	Supplementary Document	Uploaded 2010-11-22	Available
0920-10CM_SupSta_B 11[1].15.2010-clean.docx	Supporting Statement B	Uploaded 2010-11-22	Available
0920-10CM_Att8c_Local IRB Approval (UNCG).pdf	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att8b_Local IRB Approval (NYBC).pdf	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att8a_Local IRB Approval (SUNY).pdf	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att7c_Consultants (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att7b_Consultants (NYBC).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att7a_Consultants (SUNY).doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att6-References.doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att2_60-dayFRN.doc	Supplementary Document	Uploaded 2010-07-23	Available
0920-10CM_Att1_AuthorizingLegislation.doc	Supplementary Document	Uploaded 2010-07-23	Available
0920-10CM_Att5c6_Reminder Letter (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att5c5_Reminder Scripts (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att5c4_Invitation to Email Screening (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att5c3_Recruitment Script (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att5c2_Recruitment Flyer (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att5c1_Invitation to Intervention (UNCG).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att4c_Consent Forms (UNCG).doc	Supplementary Document	Uploaded 2010-07-26	Available
0920-10CM_Att5b4_Reminder Letters (NYBC).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att5b3_Telephone Scripts (NYBC).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att5b1_Recruitment Card Flyer (NYBC).doc	Supplementary Document	Uploaded 2010-07-29	Repair queued
0920-10CM_Att5b2_Script for Recruitment (NYBC).doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att4b_Consent Forms (NYBC).doc	Supplementary Document	Uploaded 2010-07-26	Repair queued
0920-10CM_Att5a3_Reminder Call Script (SUNY).doc	Supplementary Document	Uploaded 2010-07-26	Repair queued
0920-10CM_Att5a2_Contact and Appointment Card (SUNY).doc	Supplementary Document	Uploaded 2010-07-29	Available
0920-10CM_Att5a1_Recruitment Script (SUNY).doc	Supplementary Document	Uploaded 2010-07-26	Repair queued
0920-10CM_Att4a_Consent Forms (SUNY).doc	Supplementary Document	Uploaded 2010-07-26	Repair queued
0920-10CM_SupSta_A 11[1].15.2010-clean.docx	Supporting Statement A	Uploaded 2010-11-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
194338	Follow-up Assessment -- UNCG	Other-WORD	New
194337	Follow-up Assessment -- UNCG	Other-WORD	New
194336	Follow-up Assessment -- NYBC	Other-WORD	New
194335	Baseline Assessment -- NYBC	Other-WORD	New
194334	Follow-up Assessment -- SUNY	Other-WORD	New
194333	Baseline Assessment (SUNY)	Other-WORD	New
194332	Locator Form (UNCG)	Other-WORD	New
194331	Locator Form (NYBC)	Other-WORD	New
194330	Locator Form (SUNY)	Other-WORD	New
194329	Screening Form (UNCG)	Other-WORD	New
194328	Screening Form (NYBC)	Other-WORD	New
194327	Screening Form (SUNY)	Other-WORD	New

ICR Details

OMB Control No: 0920-0873	ICR Reference No: 201008-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: HIV/AIDS Risk Reduction Interventions for African-American Heterosexual Men
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/29/2010
	Date Received in OIRA: 08/19/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	24 Months From Approved
Responses	1,334	0	0
Time Burden (Hours)	335	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention requests approval for a new data collection entitled, "HIV/AIDS Risk Reduction Interventions for African-American Heterosexual Men," for two years. The purpose of this information collection is to pilot test three behavioral interventions targeting heterosexually active African American men. A limited number of HIV prevention intervention with demonstrated efficacy in reduction HIV related sexual risk behaviors have been developed and evaluated specifically for heterosexually active African American men who do not inject drugs, and who are at risk primarily due to unprotected sex with multiples or concurrent female sex partners. This project seeks to assess feasibility and acceptability of three risk reduction interventions and to collect preliminary data on the efficacy of the interventions to reduce HIV risk behaviors among the targeted population. The study design is a pilot intervention with a pre-test and post-test evaluation at three months. The project will be conducted by three sites: a) State University of New York Downstate-"SUNY" (Brooklyn, NY); (b) New York Blood Center-'NYBC'(Bronx & Harlem, NY); and (c) University of North Carolina-Greensboro-'UNCG' (Greensboro, NC). The data collection system for each site includes Screener Forms (Attachment 3a-3c), Locator Forms (Attachment 3d-3f), and Baseline and Follow-up Assessments (Attachments 3g-3i).

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act
  

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:
	75 FR 20600	04/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 43987	07/27/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Screening Form (SUNY)
Screening Form (NYBC)
Screening Form (UNCG)
Locator Form (SUNY)
Locator Form (NYBC)
Locator Form (UNCG)
Baseline Assessment (SUNY)
Follow-up Assessment -- SUNY
Baseline Assessment -- NYBC
Follow-up Assessment -- NYBC
Follow-up Assessment -- UNCG
Follow-up Assessment -- UNCG

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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	1,334	0	0	1,334	0	0
Annual Time Burden (Hours)	335	0	0	335	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $828,500

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

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: 08/19/2010

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