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

ICR 201108-0925-005

OMB: 0925-0630

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2011-08-26
IC Document Collections
IC ID
Document
Title
Status
195977 Modified
ICR Details
0925-0630 201108-0925-005
Historical Active 201101-0925-006
HHS/NIH
Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance (NHLBI)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 08/31/2011
Retrieve Notice of Action (NOA) 08/31/2011
  Inventory as of this Action Requested Previously Approved
04/30/2014 04/30/2014 04/30/2014
4,150 0 4,150
2,407 0 2,407
0 0 0

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.

US Code: 42 USC 258b-3 Name of Law: Ensure the overall safety of the blood supply
  
None

Not associated with rulemaking

Yes

1
IC Title Form No. Form Name
Blood Donors 1 Survey

  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 4,150 0 0 0 0
Annual Time Burden (Hours) 2,407 2,407 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,968,304
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Mikia Currie 3014350941

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/31/2011


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