Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)

Forms and Documents

Document Name	Status
Att 12_Univ Washington IRB Approval.pdf Supplementary Document	2015-11-12
Att 4 Certificate of Confidentiality.pdf Supplementary Document	2015-11-12
Att 3_References.docx Supplementary Document	2015-11-12
Att 2 60 Day FRN.pdf Supplementary Document	2015-11-12
Att 1_Auth Legislation.docx Supplementary Document	2015-11-12
Supporting Statement B_021616.docx Supporting Statement B	2016-02-16
Supporting Statement A_021616.docx Supporting Statement A	2016-02-16

IC Document Collections

IC ID	Document Title	Status
218949	Att 10_Phase 2 Consent Other-WORD	New
218948	Att 9_Phase 1 Consent Other-WORD	New
218947	Att 8_Behavioral Survey Other-WORD	New
218946	Att 7_Symptom and Care Survey Other-WORD	New
218945	Att 6_Enrollment Survey B Other-WORD	New
218918	Att 5_Phase 1 Enrollment Survey A Other-WORD	New

ICR Details

OMB Control No: 0920-1100	ICR Reference No: 201511-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15AEZ
Title: Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)
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: 02/16/2016
	Date Received in OIRA: 11/20/2015
Terms of Clearance: Approved consistent with the understanding that any forthcoming publications or communications of the study outcomes will clearly convey the potential limitations in the generalizability of the behavioral findings to other subpopulations and other geographic areas.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved
Responses	4,751	0	0
Time Burden (Hours)	2,110	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goals of the project are to: 1) characterize the performance of new HIV tests for detecting established and acute HIV infection at the point of care(POC)relative to each other and currently used gold standard, non-POC tests, and 2) identify behavioral and clinical predictors of early HIV infection.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Services 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:
	80 FR 27311	05/13/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 67757	11/03/2015
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Att 5_Phase 1 Enrollment Survey A
Att 6_Enrollment Survey B
Att 8_Behavioral Survey
Att 7_Symptom and Care Survey
Att 9_Phase 1 Consent
Att 10_Phase 2 Consent

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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	4,751	0	0	4,751	0	0
Annual Time Burden (Hours)	2,110	0	0	2,110	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 request for collection of information that has not previously been used or sponsored by CDC.

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Annual Cost to Federal Government: $867,704

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: 11/20/2015

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