Incident HIV/ Hepatitis B virus infections in South African blood donors:Behavioral risk factors, genotypes and biological characterization of early infection (NHLBI)

Forms and Documents

Document Name	Status
Form 1 Objective 3 Clinical Follow-up Questionaire year 2 Form and Instruction	New
Form 1 Objective 3 clinical Follow-up Questionaire Year 1 Form and Instruction	New
Form 1 Objective 3 Consent Form Form	New
Form 1 Objectives 1 and 2 ACASI Questionaire Form and Instruction	New
Form 1 Objectives 1 and 2 Consent Forms Form	New
Supporting_Statement B HIV_HBV_4Sept2013_V_8 0.docx Supporting Statement B	2014-02-27
Attachment 2C HIV_HBV_Objectives_1_2_3_Questionnaires_Justification_12_2013_V_1.0.docx Supplementary Document	2014-02-27
Attachment 3 2HIV HBV SA IAC Advisory Committee_9_2013_V_3.0.docx Supplementary Document	2014-02-27
Attachment 5 REDS-III Publications Manual_02_09_13_V_1.0.docx Supplementary Document	2014-02-27
Attachment 4 HIV HBV Protocol 5January2014_V_7.0.docx Supplementary Document	2014-02-27
Attachment 3 1 SA HIV HBV OSMB Members 3Sept2013_V_3 0.docx Supplementary Document	2014-02-27
Supporting_Statement_A_SA_HIV_HBV_4_2014_V_17 0 REVISED.docx Supporting Statement A	2014-04-30

IC Document Collections

IC ID	Document Title	Status
210554	Objective 3 Clinical Follow-up Questionaire year 2 Form and Instruction	New
210553	Objective 3 clinical Follow-up Questionaire Year 1 Form and Instruction	New
210552	Objective 3 Consent Form Form	New
210551	Objectives 1 and 2 ACASI Questionaire Form and Instruction	New
210550	Objectives 1 and 2 Consent Forms Form	New

ICR Details

OMB Control No: 0925-0699	ICR Reference No: 201402-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 21485
Title: Incident HIV/ Hepatitis B virus infections in South African blood donors:Behavioral risk factors, genotypes and biological characterization of early infection (NHLBI)
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
	Date Received in OIRA: 02/28/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved
Responses	1,281	0	0
Time Burden (Hours)	450	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: South Africa has one of the highest burdens for HIV infection in the world. The HIV epidemic in South Africa is largely heterosexual, but risk factors for infections can change and so identifying factors that contribute to the recent spread of HIV in a broad cross-section of the otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in Africa. Small previous studies suggest that the risk factors for HIV among more recently acquired (incident) infections in blood donors may differ from those of more distant (prevalent) infections. Similarly risk factors for recently acquired HBV may be different than for prevalent HBV infections. The demographic and behavioral risks associated with incident HIV and incident HBV infection have, as yet, not been formally assessed in South African blood donors using analytical study designs. Due to the high rates of HIV and HBV infection in South African blood donors, a better understanding of these risk factors can be used to modify donor screening questionnaires so as to more accurately exclude high-risk blood donors and contribute to transfusion safety. Risk factor data from this research may also provide critical information for blood banking screening strategies in other countries.

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Authorizing Statute(s): US Code: 42 USC 6A Name of Law: NHLBI
  

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 67175	11/08/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 9471	02/19/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Objectives 1 and 2 Consent Forms	1	Consent Form
Objectives 1 and 2 ACASI Questionaire	1	ACASI Questionaire
Objective 3 Consent Form	1	Objective 3 consent form
Objective 3 clinical Follow-up Questionaire Year 1	1	Clinical Questionaire Follow-up
Objective 3 Clinical Follow-up Questionaire year 2	1	Clinical Follow-up Questionaire

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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	1,281	0	0	1,281	0	0
Annual Time Burden (Hours)	450	0	0	450	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: $198,506

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: 02/28/2014

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