The Prevalence and Incidence of HIV Molecular Variants and Their Correlation with Risk Behaviors and HIV Treatment in Brazilian Blood Donors (NHLBI)

Forms and Documents

Document Name	Status
Form 2 Brazil HIV Case Study Questionnaire Form and Instruction	New
Form 1 Informed Consent Form and Instruction	New
Form 1 HIV Case Control Study Form and Instruction	Removed
Attach_4_Brazil_HIV_Protocol_10_2014_V_1 0.doc Supplementary Document	2015-03-25
Attach_3 2_Brazil_HIV_Risk_Factor_Assessment__Description of each item, source, and goal_10_2014_V_1 0.docx Supplementary Document	2015-03-25
Attach_3 3_Brazil_HIV_IAC_10_2014_V_1 0.docx Supplementary Document	2015-03-25
Attach_3 1_Brazil_HIV_OSMB_Members_10_2014_V_1.0.docx Supplementary Document	2015-03-25
Supporting_Statement_B_Brazil_HIV_12_2014_V_2.0.docx Supporting Statement B	2015-03-25
Supporting_Statement_A_HIV_Brazil_3_2015_V_9 0 (2).docx Supporting Statement A	2015-03-25

IC Document Collections

IC ID	Document Title	Status
215854	Brazil HIV Case Study Questionnaire Form and Instruction	New
215802	Informed Consent Form and Instruction	New
187011	HIV Case Control Study Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0597	ICR Reference No: 201503-0925-008
Status: Historical Active	Previous ICR Reference No: 201303-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 19140
Title: The Prevalence and Incidence of HIV Molecular Variants and Their Correlation with Risk Behaviors and HIV Treatment in Brazilian Blood Donors (NHLBI)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/05/2015
	Date Received in OIRA: 04/01/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	07/31/2015
Responses	200	0	100
Time Burden (Hours)	40	0	40
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of the interview questions is to collect donor profile data for comparing risk exposures between prospective blood donors who test HIV positive (cases) and HIV negative (controls). The responses will permit us to determine risk factors associated with HIV infection among volunteer replacement blood donors in Brazil. A case control study will yield interview data on HIV risk behaviors among prospective donors that will be used; 1) to understand predominant risk behaviors associated with in HIV positive blood donation in Brazil, for example: male-to-male sex, having multiple heterosexual partners, and to a lesser extent injection drug use (IDU), 2) the results may also lead to suggestions for modification to current operational donor screening questionnaire in ways that can decrease risk and improve blood safety. The questions for both cases and controls are identical, except for five additional questions that will be asked at the end of the interview on topics that are unique for HIV positive individuals (cases).

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Authorizing Statute(s): US Code: 42 USC 285b Name of Law: National Heart, Lung, and Blood Institute
  

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 78876	12/31/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 15218	03/23/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Brazil HIV Case Study Questionnaire	2	REDS-III Risk Factor Assessment
HIV Case Control Study	1	Questionnaire
Informed Consent	1	Attachment 2 Risk Factor Informed 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	200	100	0	100	0	0
Annual Time Burden (Hours)	40	40	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This previously approved study contained a consent form and questionnaire that imposed a 24 minutes burden hour per respondent, with 2,000 respondents' total. This consent form and questionnaire constitutes a continuation of the original 24 minutes burden hours per respondent for the approved study protocol including a consent form and questionnaire administered to HIV-positive blood donors that will be identified through routine blood donor screening. In this continuing phase of the study, no control donors will be included, so the total number of respondents has been lowered from 2,000 to 400 with expected enrollment of no more than 100 subjects per year for the remainder of the data collection period.

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Annual Cost to Federal Government: $149,162

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: 04/01/2015

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