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	New
PresidCEP belo.pdf.jpg Supplementary Document	2009-02-12
TERMO CONSETIMENTO - HEMOPE0001.pdf Supplementary Document	2009-02-12
Aprova�ao_Cappesq_06_02_2009.pdf Supplementary Document	2009-02-12
08 10 14 Full Approval for REDS 8067.99.03.02.pdf Supplementary Document	2009-02-12
Nov08 Modification CHR approval letter.pdf Supplementary Document	2009-02-12
Waiver request.doc Supplementary Document	2009-02-12
Attachment 4_Brazil_HIV_Protocol.doc Supplementary Document	2009-02-12
Attachment 2_English Consent Revised (2).doc Supplementary Document	2009-02-12
Attachment 1_English Questionnaire_Revised (2).doc Supplementary Document	2009-02-12
Attachment 4_Brazil_HIV_Protocol_English_8-May-08.doc Supplementary Document	2008-10-08
Attachment 3.3_SC Members.doc Supplementary Document	2008-10-08
Attachment 3.2_Justification.doc Supplementary Document	2008-10-08
Attachment 3.1_List of OSMB Members.doc Supplementary Document	2008-10-08
Attachment 2_English Consent .doc Supplementary Document	2008-10-08
SS-A NHLBI1.doc Supporting Statement A	2009-02-12

IC Document Collections

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

ICR Details

OMB Control No: 0925-0597	ICR Reference No: 200810-0925-006
Status: Historical Active	Previous ICR Reference No:
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: 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: 02/13/2009
	Date Received in OIRA: 10/24/2008
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	02/29/2012	36 Months From Approved
Responses	2,000	0	0
Time Burden (Hours)	800	0	0
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 241 Name of Law: Public Health Service 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:
	73 FR 30951	05/29/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 46628	08/11/2008
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	survey

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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	2,000	0	0	2,000	0	0
Annual Time Burden (Hours)	800	0	0	800	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.

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Annual Cost to Federal Government: $112,132

Does this IC contain surveys, censuses, or employ statistical methods? No

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 10/24/2008

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