Characterization of risk of HIV and HIV outcomes in the Brazilian Sickle Cell Disease (SCD) population and comparison of SCD outcomes between HIV sero-positive and negative SCD patients

Forms and Documents

Document Name	Status
Form 3 Objectives 1 and 2 Risk Factor Assessment Form and Instruction	New
Form 2 Objective 2 Risk Factor Informed Consent Adult HIV positive SCD patients Form and Instruction	New
Form 1 Objective 1 Risk Factor Adult SCD cases and non-SCD controls Informed Consent Form and Instruction	New
Supporting_Statement_B_Brazil_SCD_3_2016_V_8.0_OMB.docx Supporting Statement B	2016-03-11
Supporting_Statement_A_Brazil_SCD_3_2016_V_12.0.docx Supporting Statement A	2016-03-11
Attachment_4_Brazil_SCD_Protocol_2015-05-018_V_6.0.docx Supplementary Document	2015-09-21
Attachment_3.3_Brazil_SCD_IAC_10_2014_V_1 0.docx Supplementary Document	2015-09-21
Attachment_3.2_Brazil_SCD_Risk_Factor_Assessment_Description of each item, source, and goal_9_2015_V_4.0.docx Supplementary Document	2015-09-21
Attachment_3.1_Brazil_SCD_OSMB_Members_10_2014_V_1.0.docx Supplementary Document	2015-09-21
NHLBI 30day FRN.pdf Supplementary Document	2015-09-21

IC Document Collections

IC ID	Document Title	Status
218306	Objectives 1 and 2 Risk Factor Assessment Form and Instruction	New
218303	Objective 2 Risk Factor Informed Consent Adult HIV positive SCD patients Form and Instruction	New
218302	Objective 1 Risk Factor Adult SCD cases and non-SCD controls Informed Consent Form and Instruction	New

ICR Details

OMB Control No: 0925-0736	ICR Reference No: 201509-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Characterization of risk of HIV and HIV outcomes in the Brazilian Sickle Cell Disease (SCD) population and comparison of SCD outcomes between HIV sero-positive and negative SCD patients
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: 03/11/2016
	Date Received in OIRA: 09/30/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved
Responses	650	0	0
Time Burden (Hours)	325	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The limited studies focused on HIV in SCD have suggested a lower prevalence of HIV in SCD compared to a non-SCD population. While some investigators have suggested that perhaps SCD pathophysiology has a unique effect on HIV infection or replication, none of the studies adequately measured risk of HIV in SCD. Objective 1 of the proposed study is to compare HIV risk factors between 150 SCD cases randomly selected from the REDS-III Brazilian SCD Cohort and 150 controls from a demographically similar population. An assessment that has been well validated in previous REDS-II HIV studies has been modified for the SCD population and will be used to collect data regarding HIV risk behaviors. Objective 2 will seek to enroll approximately 25 SCD patients diagnosed with HIV infection as part of routine clinical care at REDS-III participating centers in the previous 10 years and abstract detailed information regarding the HIV infection and SCD from medical records. This will allow a detailed case series description of HIV outcomes in this population (Objective 2a). Finally, HIV negative controls matched on age, gender, SCD type and center to the identified HIV sero-positive SCD patients will be selected from the REDS-III SCD cohort to compare SCD outcomes between HIV positive and HIV negative subjects (Objective 2b). The HIV negative controls have already consented to participate in REDS-III research; therefore, their SCD outcomes will be extracted from the REDS-III SCD cohort dataset. No re-contact will be required, and no assessment will be administered to this group of HIV negative controls. This study will provide critical information to guide the management and future research for patients with HIV and SCD in Brazil, the United States and worldwide.

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Authorizing Statute(s): US Code: 42 USC Chapter 6A, sect. 285b-1 Name of Law: NHLBI Purpose
  

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 32388	06/08/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 55141	09/14/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Objective 1 Risk Factor Adult SCD cases and non-SCD controls Informed Consent	1	Attachment 2.1 Brazil SCD Obj. 1 Risk Factor Assessment Consent
Objective 2 Risk Factor Informed Consent Adult HIV positive SCD patients	2	Attachment 2.2 Brazil SCD Obj. 2 Risk Factor Assessemtn Consent
Objectives 1 and 2 Risk Factor Assessment	3	Brazil SCD Rick Factor Assessment

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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	650	0	0	650	0	0
Annual Time Burden (Hours)	325	0	0	325	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 submission

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Annual Cost to Federal Government: $38,114

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: 09/30/2015

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