The effectiveness of donor notification, HIV, counseling, and linkage of HIV positive donors to health care in Brazil

Forms and Documents

Document Name	Status
Form 2 ACASI Questionnaire Form and Instruction	New
Form 1 ACASI Questionnaire Informed Consent Form and Instruction	New
Attach_7_Invitation_Letter_English_Portuguese_1__2015_V_9.0.docx Supplementary Document	2015-11-03
Attach_4_REDSIII_Brazil_Notification_HIV_Protocol_1_2015_V_9 0.docx Supplementary Document	2015-11-03
Attach_3.1_OSMB_Members_7_2014_V_1.0.docx Supplementary Document	2015-11-03
Attach_3 3_Brazil_HIV_IAC_9_2014_V_2.0.docx Supplementary Document	2015-11-03
Attach_3 2_ACASI_Questionnaire_Description of each item source and goal_10_2014_V_7.0.docx Supplementary Document	2015-11-03
SSB_Brazil_notification_10_2014_V_8.0.docx Supporting Statement B	2015-11-03
SSA_Brazil_HIV_Notification_6_2015_V_24.0.docx Supporting Statement A	2015-11-03

IC Document Collections

IC ID	Document Title	Status
218845	ACASI Questionnaire Form and Instruction	New
218844	ACASI Questionnaire Informed Consent Form and Instruction	New

ICR Details

OMB Control No: 0925-0726	ICR Reference No: 201511-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The effectiveness of donor notification, HIV, counseling, and linkage of HIV positive donors to health care in Brazil
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 without change	Conclusion Date: 11/13/2015
	Date Received in OIRA: 11/04/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved
Responses	550	0	0
Time Burden (Hours)	229	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This proposed study, “The effectiveness of donor notification, HIV counseling, and linkage of HIV positive donors to health care in Brazil” (The Brazil Notification Study)”, addresses this significant information gap with three objectives. The first objective formally measures donor notification rates in Brazil. The second objective measures HIV follow-up rates and donor behavior in relation to activities, such as linkage to health care resources and behavioral risk reduction through monitoring and counseling after donor notification. The third objective seeks to find ways to improve the disclosure of HIV risks during donor eligibility assessment at the time of blood donation. We will enroll a cohort of HIV-positive donors to assess these three objectives. Our findings will yield insights into improved methods for donor self-selection and qualification post donation, which will serve to decrease the frequency of higher-risk persons acting as donors. Our findings on improved methods for Brazilian donor notification and linkage to health care services may also be applicable to developed countries, including the US. Results of the Brazil Notification Study will identify how to improve notification and counseling strategies that increase the number of HIV-positive donors seeking prompt medical care. This might ultimately boost strategies to prevent secondary HIV transmission and reduce the risk of transfusion-transmission.

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Authorizing Statute(s): US Code: 42 USC sect 285b-1 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:
	80 FR 18853	04/08/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 37277	06/30/2015
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
ACASI Questionnaire Informed Consent	1, 3	Attachment 2 ACASI Questionnaire Informed Consent ,   Attachment 6 ACASI Questionnaire Informed Consent PORTUGUESE
ACASI Questionnaire	2, 4	Attachment 1 ACASI Questionnaire English ,   Attachment 5 ACASI Questionnaire Portuguese

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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	550	0	0	550	0	0
Annual Time Burden (Hours)	229	0	0	229	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: New ICR

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Annual Cost to Federal Government: $131,724

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: 11/04/2015

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