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Federal forms, ICRs, and supporting documents

Information Collection Request

Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

ICR 201403-0910-008 · OMB 0910-0681 · Historical Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-03-19
IC Document Collections
IC ID
Document
Title
Status
195896 Modified
ICR Details
0910-0681 201403-0910-008
Historical Active 201101-0910-002
HHS/FDA 21601
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion
Extension without change of a currently approved collection   No
Regular
Approved without change 04/29/2014
Retrieve Notice of Action (NOA) 03/21/2014
  Inventory as of this Action Requested Previously Approved
04/30/2017 36 Months From Approved 04/30/2014
1 0 1
1 0 1
0 0 0
The guidance recommends that establishments that manufacture Whole Blood and blood components intended for transfusion should notify consignees of all previously collected in-date blood and blood components to quarantine and return the blood and blood components to establishments or to destroy them within 3 calendar days after a donor tests repeatedly reactive by a licensed test for T. cruzi antibody. When establishments identify a donor who is repeatedly reactive by a licensed test for T. cruzi antibodies and for whom there is additional information indicating risk of T. cruzi infection, such as testing positive on a licensed supplemental test (when such test is available) or until such test is available, information that the donor or donor's mother resided in an area endemic for Chagas disease (Mexico, Central and South America) or as a result of other medical diagnostic testing of the donor indicating T. cruzi infection, FDA recommends that the establishment notify consignees of all previously distributed blood and blood components collected during the "lookback" period, and, if blood or blood components were transfused, to encourage consignees to notify the recipient's physician of record of a possible increased risk of T. cruzi infection. The notification of consignees and of the recipient's physician of record is intended to provide the necessary information regarding possible increased risk of T. cruzi infection. All donors who test repeatedly reactive should be counseled to seek a physician's advice. It also may be helpful to refer them to their state and local health departments or to other appropriate community resources.
US Code: 42 USC 262 Name of Law: PHS Act
   US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act
  
None
Not associated with rulemaking
  78 FR 46954 08/02/2013
79 FR 12506 03/05/2014
No
  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 1 1 0 0 0 0
Annual Time Burden (Hours) 1 1 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
  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.
03/21/2014