Evaluation of Free Rapid HIV at-home Testing

OMB Control No: 0920-1018	ICR Reference No: 201403-0920-017
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 21551
Title: Evaluation of Free Rapid HIV at-home Testing
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: 05/16/2014
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/31/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved
Responses	66,592	0	0
Time Burden (Hours)	7,085	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study is a randomized trial which aims to evaluate the use and effectiveness of home-test kits as a public health strategy for increasing testing among MSM. A secondary aim is to evaluate the extent to which MSM (both HIV-negative and HIV-positive) distribute HIV home-test kits to their social and sexual networks.

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Authorizing Statute(s): US Code: 42 USC 241 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:
	78 FR 66008	11/04/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 14252	03/13/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title Form No. Form Name Consent none Consent Focus Group Consent none Consent In-depth Interview Consent none Consent Baseline Survey for RCT none Baseline Survey Baseline Survey for HIV-Positive Group none Baseline Survey Reporting of Test Results (during study) none Reporting Home Test Results Follow-up Survey for RCT none Follow-up Survey Follow-up Survey for HIV Positive Group none Follow-up Survey Reportng Test Results (completion of study) none Reporting Home Test Results completion Focus Group Discussion none Focus Group Discussion Guide In-depth Interview none Individual in-depth Interview Guide Eligibility Screener form Eligibility Screener Study Registration none Registration

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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	66,592	0	0	66,592	0	0
Annual Time Burden (Hours)	7,085	0	0	7,085	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 data collection request.

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Annual Cost to Federal Government: $545,750

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

Agency Contact: Carol Marsh 404 639-4773 [email protected]

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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: 03/31/2014

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