HIV Prevention among Latino MSM: Evaluation of a locally developed intervention

Forms and Documents

Document Name	Status
Rev Supporting Statement B-HIV Prevention among Latino MSM.docx Supporting Statement B	2012-06-12
Attachments 6a-6b - Two Versions of Study Ads.docx Supplementary Document	2012-06-12
Attachment 11 - CAB membership list.docx Supplementary Document	2012-02-08
Attachment 10 - All-PI meeting participant list.docx Supplementary Document	2012-02-08
Attachment 9 - NCHHSTP project determination.pdf Supplementary Document	2012-02-08
Attachment 8 - Local IRB approvals.pdf Supplementary Document	2012-02-08
Attachment 1 - Public Health Service Act.docx Supplementary Document	2012-02-08
Attachment 7 - Consent forms.pdf Supplementary Document	2012-02-08
Supporting Statement A-HIV Prevention among Latino MSM.docx Supporting Statement A	2012-06-12

IC Document Collections

IC ID	Document Title	Status
201268	6-Month Follow-up Assessment Other-Attachment 5 - Six-Month Follow-Up Assessment	New
201267	Baseline Assessment Questionnaire Other-Attachment 4 Baseline Assessment questionnaire	New
201266	Participant Screening Form Other-Attachment 3	New

ICR Details

OMB Control No: 0920-0942	ICR Reference No: 201202-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: HIV Prevention among Latino MSM: Evaluation of a locally developed intervention
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: 06/28/2012
	Date Received in OIRA: 02/15/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	36 Months From Approved
Responses	950	0	0
Time Burden (Hours)	883	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study will use a randomized controlled trial design to collect data needed to assess the efficacy of the Spanish-language, small-group HOLA en Grupos intervention compared to a general health comparison intervention.

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Authorizing Statute(s): None

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:
	76 FR 206	10/25/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 6802	02/09/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Participant Screening Form
Baseline Assessment Questionnaire
6-Month Follow-up Assessment

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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	950	0	0	950	0	0
Annual Time Burden (Hours)	883	0	0	883	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 ICR

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Annual Cost to Federal Government: $653,943

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? Yes

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: 02/15/2012

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