Does Pre-Donation Behavioral Deferral Increase the Safety of the Blood Supply (NHLBI)

Forms and Documents

Document Name	Status
Attachment 2_Revised Deferral Study Qx English.doc Supplementary Document	2010-08-13
Supporting Statement B_0115_revised.doc Supporting Statement B	2010-02-25
Attachment_6_Deferral_Qx_Justification_080910 (2).docx Supplementary Document	2010-08-16
Attachment 5_OSMB Members.doc Supplementary Document	2010-02-25
Attachment 4_SC Members.doc Supplementary Document	2010-02-25
Attachment 3_ Deferral Study Protocol.doc Supplementary Document	2010-02-25
Attachment 1_Title 22.doc Supplementary Document	2010-02-25
Attachment 7_Revised Deferral study Informed consent English.doc Supplementary Document	2010-08-13
Supporting Statement A.doc Supporting Statement A	2010-04-30

IC Document Collections

IC ID	Document Title	Status
193150	Defferal Questionnaire Other- Deferral Study Consent Form Portuguese	New

ICR Details

OMB Control No: 0925-0620	ICR Reference No: 201006-0925-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Does Pre-Donation Behavioral Deferral Increase the Safety of the Blood Supply (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: 08/16/2010
	Date Received in OIRA: 06/04/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	36 Months From Approved
Responses	4,860	0	0
Time Burden (Hours)	1,604	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The present study will expand upon previous research by specifically assessing disease marker prevalence in deferred donors while also determining motivations for attempting to donate and whether additional risk factors are present using a audio-computer assisted interview (ACASI). This study will focus on the safety impact of several sexual exposure category deferrals; multiple sexual partners, male to male sex, exchanging money or drugs for sex, sex with a partner who has HIV, etc. Objectives: The main objectives of the study are: 1. Assess infectious disease marker prevalence in donors who are deferred for higher risk sexual and non-injection drug use behavior. 2. Determine if the deferral classification procedures and coding used by different blood centers in Brazil leads to a measurable difference in disease marker prevalence in deferred donors between those centers that use specific behavior codes and those centers that use non-specific deferral codes.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health and Welfare
  

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:
	75 FR 8367	02/24/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 25268	05/07/2010
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
Defferal 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	4,860	0	0	4,860	0	0
Annual Time Burden (Hours)	1,604	0	0	1,604	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: $224,264

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]? Uncollected

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: 06/04/2010

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