Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance (NHLBI)

Forms and Documents

Document Name	Status
Form 1 Blood Donors Form and Instruction	New
Response Memo.doc Supplementary Document	2011-04-08
Attachment 8_Risk Factor Study information mailer for controls.doc Supplementary Document	2011-04-08
Attachment 7_Risk Factor Study information mailer for cases.doc Supplementary Document	2011-04-08
Revised Supporting Statement B.doc Supporting Statement B	2011-04-08
Attachment 3_ QXQ questionnaire description.doc Supplementary Document	2010-12-17
Protocol Summary.docx Supplementary Document	2010-12-17
Attachment 1_Study Protocol.docx Supplementary Document	2010-12-17
Attachment 6_Risk-Factor-comments-11-16-2010.pdf Supplementary Document	2010-12-17
Attachment 5_NHLBI Certificate of Confidentiality NHLBI 09-13.pdf Supplementary Document	2010-12-17
Attachment 4_Privacy Act Memo.pdf Supplementary Document	2010-12-17
Revised Supporting Statement A.doc Supporting Statement A	2011-04-08

IC Document Collections

IC ID	Document Title	Status
195977	Blood Donors Form and Instruction	New

ICR Details

OMB Control No: 0925-0630	ICR Reference No: 201101-0925-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance (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: 04/08/2011
	Date Received in OIRA: 01/18/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved
Responses	4,150	0	0
Time Burden (Hours)	2,407	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Information on current risk factors in blood donors as assessed using analytical study designs is largely unavailable in the US. This project represents a collaborative pilot research study that will include a comprehensive interview study of viral infection positive blood donors at the American Red Cross (ARC), Blood Systems Inc. (BSI) and New York Blood Center (NYBC) in order to identify the current predominant risk factors for virus positive donations and will also establish a donor biovigilance capacity that currently does not exist in the US. At this time it is not easy to integrate risk factor data and disease marker surveillance information within or across different blood collection organizations because common interview procedures and laboratory confirmation procedures are not being used and so we cannot easily tabulate and analyze behavioral risks or viral infections in US blood donors. This creates the potential for gaps in our understanding of absolute incidence and prevalence as well as risks that could lead to transfusion-transmitted disease.

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Authorizing Statute(s): US Code: 42 USC 258b-3 Name of Law: Ensure the overall safety of the blood supply
  

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 59724	09/28/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 79006	12/17/2010
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Blood Donors	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	4,150	0	0	4,150	0	0
Annual Time Burden (Hours)	2,407	0	0	2,407	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 ICR.

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Annual Cost to Federal Government: $1,968,304

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: 01/18/2011

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