Community Context Matters Study

Forms and Documents

Document Name	Status
Key Stakeholder Interview Form	Modified
Neighborhood Interview Form	Modified
SS_Part B. doc.doc Supporting Statement B	2016-05-12
CHANGE_REQUEST_201408-0920-1038_May2016.docx Justification for No Material/Nonsubstantive Change	2016-05-12
SS_PartA.docx Supporting Statement A	2016-05-12
Philly_IRB_ContxtMatters_2014.pdf Supplementary Document	2014-08-13
6531 New Site Restricted Approval.docx Supplementary Document	2014-08-13
Full Board Approval -- #14.03.01 (Michaels) Initial Submission.pdf Supplementary Document	2014-08-13
Att 2 60Day FRN.pdf Supplementary Document	2014-08-11
Att 1_Auth Legislation.docx Supplementary Document	2014-08-11

IC Document Collections

IC ID	Document Title	Status
212650	Key Stakeholder Interview Form	Modified
212624	Neighborhood Interview Form	Modified
212623	Key Stakeholder Recruitment and Consent Instruction	Unchanged
212621	Neighborhood Interview Recruitment and Consent Instruction	Modified

ICR Details

OMB Control No: 0920-1038	ICR Reference No: 201605-0920-006
Status: Historical Active	Previous ICR Reference No: 201408-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 16AJC
Title: Community Context Matters Study
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/26/2016
	Date Received in OIRA: 05/12/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	12/31/2017	12/31/2017
Responses	600	0	500
Time Burden (Hours)	110	0	91
Cost Burden (Dollars)	0	0	0

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Abstract: The daily use of specific antiretroviral medications by persons without HIV, but at high risk of exposure to HIV, has been shown to be a safe and effective HIV prevention method. The FDA approved the use of Truvada® for preexposure prophylaxis (PrEP) and CDC has issued clinical practice guidelines for its use. CDC requests approval to assess the utility of new measures developed or adapted to collect information related to this new intervention and to evaluate community contextual factors that may impact the acceptability and successful introduction of a new HIV prevention method. The project will be conducted in communities where PrEP has become available through a local community health center - a community-based survey in public venues in the catchment areas of the PrEP clinics, and key stakeholder surveys community HIV leaders. The surveys will collect demographic data, knowledge of PrEP, misinformation about PrEP, and attitudes about it. This request is to add another clinic and change 2 of the survey sites.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: PHSA
  

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:
	79 FR 24439	04/30/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 47465	08/13/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Key Stakeholder Recruitment and Consent	none	Key Stateholder Informed Consent
Neighborhood Interview	none	Neighborhood Survey
Neighborhood Interview Recruitment and Consent
Key Stakeholder Interview	none	Key Stakeholder Interview

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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	600	500	0	100	0	0
Annual Time Burden (Hours)	110	91	0	19	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: Request to add respondents due to adding a clinic to increase respondent diversity, changing some of the study sites, and a minor wording change in one question. Burden increase due to increase in respondents.

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Annual Cost to Federal Government: $234,700

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: 05/12/2016

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