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 1 HIV Case Control Study Form and Instruction	Modified
Supporting_Statement_B_Brazil_HIV_4_2012_V_4 0.docx Supporting Statement B	2012-04-26
Attachment_5_CoC_4_2012_V_1.01.doc Supplementary Document	2012-04-26
Attach_4_Brazil_HIV_Protocol_4_2012_V_2.0.doc Supplementary Document	2012-04-26
Attach_3.3_Brazil_HIV_Oversight_Committee_4_2012_V_2.0.docx Supplementary Document	2012-04-26
Attach_3.2_Brazil_HIV_Case_Study_Questionnaire__Description of each item, source, and goal_4_24_2012_V_5.0.docx Supplementary Document	2012-04-26
Attach_3.1_Brazil_HIV_OSMB_Members_4_2012_V_2.0.docx Supplementary Document	2012-04-26
Attach_7_ Brazil_HIV_Informed_Consent_Portuguese_4_2120_V_1.0.docx Supplementary Document	2012-04-30
Attach_6_Brazil_HIV_Case_Study_Questionnaire_Portuguese_4_2102_V_1 0.docx Supplementary Document	2012-04-30
Attach_2_Brazil_HIV_Informed Consent_4_2012_V_2.0.docx Supplementary Document	2012-04-30
Supporting_Statement_A_HIV_Brazil_4_30_2012_V_10.0.docx Supporting Statement A	2012-04-30

IC Document Collections

IC ID	Document Title	Status
187011	HIV Case Control Study Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0597	ICR Reference No: 201205-0925-001
Status: Historical Active	Previous ICR Reference No: 200810-0925-006
Agency/Subagency: HHS/NIH	Agency Tracking No:
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/03/2012
	Date Received in OIRA: 05/02/2012
Terms of Clearance: Approved consistent with previous Terms of Clearance: Approved consistent with revised documents uploaded on 02/12/2009. OMB understands that the project will be using the basic race and ethnicity categories of the Brazilian Institute of Geography and Statistics (IBGE), rather than the standard OMB categories, given that this study is being carried out exclusively in Brazil.

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

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Abstract: The purpose of the information collection is to determine risk factors associated with HIV infection, HIV subtype, and drug resistance profile among HIV positive blood donors in Brazil according to HIV status, year of donation, and site of collection.

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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:
	70 FR 2072	01/13/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 21785	04/11/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
HIV Case Control Study	1	Questionnaire

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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	100	0	0	100	0	0
Annual Time Burden (Hours)	40	0	0	40	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: The previously approved study contained a 24 minute long questionnaire that imposed a 0.40 burden hour per respondent, with 2,000 respondents total. This questionnaire constitutes a reinstatement of the identical 0.40 respondent burden hours per respondent for the approved study protocol including a 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 100 subjects per year for a four year 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: 05/02/2012

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